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 Instructions for Use (IFU) and Product Manuals for Healthcare Professionals

​​​​​​​​​​​​​​​​​From this webpage you can view, print or order IFUs and technical manuals free of charge for many Orthofix products.

Please note:

  • IFUs/Manuals should be reviewed before using or implanting a device, or performing follow-up care.
  • IFUs/Manuals are subject to change; the most current version is always available on this site.
  • IFUs/Manuals for all products may not be available on this site. If you do not find the manual you seek, please contact your Orthofix sales representative or Orthofix Customer Service at 1-214-937-3199 or 1-888-298-5700.

 Biologics Instructions for Use (IFU) for Healthcare Professionals

 Extremity Fixation Instructions for Use (IFU) for Healthcare Professionals

​​​​UPPER EXTREMITY​​​​
​​​Bone Screws​

Orthofix External Fixation System
Orthofix Fixation System Medical Devices

Orthofix Bone Screws for External Fixation System
Risks due to the Re-Use of "Single Use" Device​​​​​​

​​Centro​nail Titanium Humeral Nail (Not Sold ​in the U.S.A.)

Orthofix Internal Fixation System
Orthofix Fixation System Medical Devices

Risks due to the Re-Use of "Single Use" Device​​​​​​
Orthofix Titanium Nailing System

​Contours PHP 
(Not Sold ​in the U.S.A.)
 Orthofix LSP Titanium Humeral Plate System

 Orthofix Contours PHP Proximal Humeral Plate System

Orthofix Fixation System Medical Devices
Risks due to the Re-Use of "Single Use" Device​​​​​​

​​Contours VPS® 
(Not Sold ​in the U.S.A.)
Contours VPS Volar Plating System (Bone Plate)
​Contours VPS®-3 Contours VPS Volar Plating System (Bone Plate))
​Elbow Fixator
(Not Sold ​in the U.S.A.)
Orthofix External Fixation System
Orthofix Fixation System Medical Devices

Orthofix Bone Screws for External Fixation System
Risks due to the Re-Use of "Single Use" Device​​​​​​ 
​​Flexible Reamers​Flexible Reamer System
Orthofix Fixation System Medical Devices 
​Fragment Fixation System
(Not Sold ​in the U.S.A.)
Orthofix Bone Screws for External Fixation System
Orthofix External Fixation System
Orthofix Internal Fixation System

Orthofix Fixation System Medical Devices​​
Risks due to the Re-Use of "Single Use" Device​​​​​​

​GALAXY WristOrthofix Galaxy Fixation System Orthofix Bone Screws for External Fixation System Risks due to the Re-Use of "Single Use" Device​​​​​​
​GALAXY Fixation​ Orthofix Galaxy Fixation System
Galaxy - TL-HEX Connection System
Orthofix Bone Screws for External Fixation System
Risks due to the Re-Use of "Single Use" Device​​​​​​
​MiniRail System Orthofix External Fixation System

Orthofix Fixation System Medical Devices

Orthofix Bone Screws for External Fixation System
Risks due to the Re-Use of "Single Use" Device​​​​​​
​Pennig Dynamic Wrist Fixator

Orthofix External Fixation System
​​Orthofix Fixation System Medical Devices

Orthofix Bone Screws for External Fixation System
Risks due to the Re-Use of "Single Use" Device​​​​​​

​Pennig MiniFixator​Orthofix External Fixation System

Orthofix Fixation System Medical Devices

Orthofix Bone Screws for External Fixation System
Risks due to the Re-Use of "Single Use" Device​​​​​​
​ProCallus FixatorOrthofix External Fixation System
Orthofix Fixation System Medical Devices
Orthofix Bone Screws for External Fixation System
Risks due to the Re-Use of "Single Use" Device​​​​​​
​RadioLucent​ Wrist Fixator

Orthofix External Fixation System

Orthofix Bone Screws for External Fixation System
Risks due to the Re-Use of "Single Use" Device​​​​​​
​XCaliber® Meta-Diaphyseal
Fixator
Orthofix Fixation System Medical Devices

Orthofix External Fixation System

Orthofix Bone Screws for External Fixation System
Risks due to the Re-Use of "Single Use" Device​​​​​​
​XWires (Not Sold ​in the U.S.A.)Orthofix External Fixation System




​​​​LOWER EXTREMITY​​​​​​ ​ ​
​AHN Ankle Hindfoot Nailing System
Instruction leaflet - Orthofix  Ankle Hindfoot Nailing (AHN) SystemInstruction for safe processing of the Orthofix  Ankle Hindfoot Nailing  System
​Bone Screws​A​ddendum Leaflet
Orthofix External Fixation System
Orthofix Fixation System Medical Devices​​
Orthofix Bone Screws for External Fixation System
Risks due to the Re-Use of "Single Use" Device​​​​​​​​​​​​
​Calcaneal MinifixatorOrthofix External Fixation System
Orthofix Fixation System Medical Devices
Risks due to the Re-Use of "Single Use" Device​​​​​​
​Centronail Titanium Femoral Nail (Not Sold ​in the U.S.A.)Orthofix Internal Fixation System
Orthofix Fixation System Medical Devices ​​​
Risks due to the Re-Use of "Single Use" Device​​​​​​ 
Orthofix Titanium Nailing System
​Centronail Titanium 
Supracondylar & Retrograde Nail (Not Sold ​in the U.S.A.)
O​rthofix Internal Fixation System

Orthofix Fixation System Medical Devices

Risks due to the Re-Use of "Single Use" Device​​​​​​ 
Orthofix Titanium Nailing System
​Centronail Titanium Tibial Nail
(Not Sold ​in the U.S.A.)
Orthofix Internal Fixation System

Orthofix Fixation System Medical Devices

Risks due to the Re-Use of "Single Use" Device​​​​​​
Orthofix Titanium Nailing System
​CHIMAERA Hip Fracture System™
CHIMAERA Hip Fracture System™ - Trocanteric Nailing System
​​Contours LPSContours Lapidus Plating System (bone plate)
​Flexible ReamersFlexible Reamer SystemOrthofix Fixation System Medical Devices
​Fragment Fixation System
(Not Sold ​in the U.S.A.)

Orthofix OsteoTite Bone Screws with Hydroxyapatite Coating
PQ ASS A 06-11
Orthofix External Fixation System

Orthofix Internal Fixation System

Orthofix Fixation System Medical Devices​​
Risks due to the Re-Use of "Single Use" Device​​​​​​

​Galaxy UNYCOOrthofix Galaxy UNYCO System
GALAXY Fixation​Orthofix Galaxy Fixation System
Galaxy - TL-HEX Connection System
Orthofix Bone Screws for External Fixation System
Risks due to the Re-Use of "Single Use" Device​​​​​​
​G-BEAM™ Fusion Beaming System
Orthofix G-Beam™ Fusion Beaming System
​​Gotfried PC.C.P. Orthofix Fixation System Medical Devices

 The Gotfried Percutaneous Comp ression Plate (PC.C.P.)

Risks due to the Re-Use of "Single Use" Device​​​​​​
​​ISKD
(Not Sold ​in the U.S.A.)
(Not Cleared by the FDA)
ORTHOFIX ISKD - SYSTEM INTRAMEDU LLARY SKELETAL KINETIC DISTRACTOR (Internal Limb Lengthener)
​​LRS ADVancedOrthofix LRS Dyna Block

Orthofix External Fixation System
Orthofix Fixation System Medical Devices

Orthofix Limb Reconstruction System
Orthofix Bone Screws for External Fixation System

Risks due to the Re-Use of "Single Use" Device​​​​​​
​MiniRail​ System Orthofix External Fixation System

Orthofix Fixation System Medical Devices

Orthofix Bone Screws for External Fixation System
Risks due to the Re-Use of "Single Use" Device​​​​​​
​OSCAR3OSCAR - Ultrasonic Arthroplasty Revision
​Pelvic Fixator
(Not Sold ​in the U.S.A.)
Orthofix External Fixation System

Orthofix Fixation System Medical Devices

Orthofix Bone Screws for External Fixation System
Risks due to the Re-Use of "Single Use" Device​​​​​​
​Pennig MiniFixatorOrthofix External Fixation System

Orthofix Fixation System Medical Devices

Orthofix Bone Screws for External Fixation System
Risks due to the Re-Use of "Single Use" Device​​​​​​
​Pertrochanteric Fixator 
(Not Sold ​in the U.S.A.)
Orthofix Bone Screws for External Fixation System
Risks due to the Re-Use of "Single Use" Device​​​​​​
​Prefix 2
(Not Sold ​in the U.S.A.)
(Not Cleared by the FDA)
Orthofix External Fixation System
Orthofix Fixation System Medical Devices
Orthofix Prefix 2
Orthofix Bone Screws for External Fixation System
Risks due to the Re-Use of "Single Use" Device​​​​​​
​​ProCallus FixatorOrthofix External Fixation System

Orthofix Fixation System Medical Devices

Orthofix Bone Screws for External Fixation System
Risks due to the Re-Use of "Single Use" Device​​​​​​
​RIVALBITE Compression Screws™
View Plating System™ - Reduce Fracture Plating System™
​Retronail Ankle Arthrodesis
(Not Sold ​in the U.S.A.)
Orthofix Internal Fixation System

Orthofix Fixation System Medical Devices

Risks due to the Re-Use of "Single Use" Device​​​​​​
​Sheffield Ring Fixator
(Not Sold ​in the U.S.A.)
Orthofix External Fixation System

Orthofix Fixation System Medical Devices

 Orthofix Bone Screws for External Fixation System
​Stainless Steel Antegrade Nails (Not Sold ​in the U.S.A.)​Orthofix Internal Fixation System

Orthofix Fixation System Medical Devices

 Risks due to the Re-Use of "Single Use" Device​​​​​​
​TL-HEX

Orthofix Fixation System Medical Devices
Orthofix Bone Screws for External Fixation System
Risks due to the Re-Use of "Single Use" Device​​​​​​

Galaxy - TL-HEX Connection System

TrueLok RockerRail

Centering Pin Kit (56-24020)

TL-HEX TrueLok Hexapod System (TL-HEX) External Fixation System

TrueLok External Fixation System
TrueLok External Fixation System TrueLok Screws
TrueLok Wire Tensioner (54-1139)

 TrueLok Wire Tensioning and Locking Elements

TrueLok and TL-HEX Dynamization Module (Dynamo)

​TrueLok

Orthofix Fixation System Medical Devices
Orthofix Bone Screws for External Fixation System
Risks due to the Re-Use of "Single Use" Device​​​​​​

TrueLok RockerRail

Centering Pin Kit (56-24020)

TL-HEX TrueLok Hexapod System (TL-HEX) External Fixation System
TrueLok External Fixation System
TrueLok External Fixation System TrueLok Screws
TrueLok Wire Tensioner (54-1139)

TrueLok Wire Tensioning and Locking Elements

TrueLok and TL-HEX Dynamization Module (Dynamo)

​​​Veronail Titanium Trochanteric Nail (Not Sold ​in the U.S.A.)Orthofix Fixation System Medical Devices

Risks due to the Re-Use of "Single Use" Device​​​​​​
Orthofix Titanium Trochanteric Nailing System

​​XCaliber® Articulated Ankle
Fixator 
Orthofix OsteoTite Bone Screws with Hydroxyapatite Coating

Orthofix External Fixation System
Orthofix Fixation System Medical Devices

Orthofix Bone Screws for External Fixation System
Risks due to the Re-Use of "Single Use" Device​​​​​​

​XCaliber® Hybrid FixatorOrthofix OsteoTite Bone Screws with Hydroxyapatite Coating

Orthofix External Fixation System
Orthofix Fixation System Medical Devices

Orthofix Bone Screws for External Fixation System
Risks due to the Re-Use of "Single Use" Device​​​​​​
​XCaliber® Meta-Diaphyseal FixatorOrthofix OsteoTite Bone Screws with Hydroxyapatite Coating

Orthofix External Fixation System
Orthofix Fixation System Medical Devices

Orthofix Bone Screws for External Fixation System
Risks due to the Re-Use of "Single Use" Device​​​​​​
​XWires​ (Not Sold ​in the U.S.A.)Orthofix External Fixation System​​





​​​PEDIATRICS ​ ​​​ ​ ​
​AGILE NAIL
Orthofix AGILE NAIL
​Bone Screws​

Addendum Leaflet
Orthofix External Fixation System
Orthofix Fixation System Medical Devices

Orthofix Bone Screws for External Fixation System
Risks due to the Re-Use of "Single Use" Device​​​​​​
​​Fragment Fixation System
(Not Sold ​in the U.S.A.)

​​Orthofix OsteoTite Bone Screws with Hydroxyapatite Coating
PQ ASS A 06-11
Orthofix External Fixation System

Orthofix Internal Fixation System

Orthofix Fixation System Medical Devices​​
Risks due to the Re-Use of "Single Use" Device​​​​​​

​GALAXY FixationOrthofix Galaxy Fixation System
Galaxy - TL-HEX Connection System
Orthofix Bone Screws for External Fixation System
Risks due to the Re-Use of "Single Use" Device​​​​​​
​eight-Plate Plus™
Guided Growth Plate System Plus
​Guided Growth System®

Guided Growth System (bone plate) eight-Plate

Guided Growth System (Stainless Steel)

​LRS PediatricOrthofix External Fixation System

Orthofix Fixation System Medical Devices

Orthofix Bone Screws for External Fixation System
Risks due to the Re-Use of "Single Use" Device​​​​​​
​M2 Multiplanar MiniRailOrthofix External Fixation System

Orthofix Fixation System Medical Devices

Risks due to the Re-Use of "Single Use" Device​​​​​​
​MJ-FLEX Orthofix MJ-FLEX the new metaizeau nail™
​Pennig Dynamic Wrist Fixator Orthofix External Fixation System

Orthofix Fixation System Medical Devices 

Orthofix Bone Screws for External Fixation System
Risks due to the Re-Use of "Single Use" Device​​​​​​
​Pennig MiniFixatorOrthofix External Fixation System

Orthofix Fixation System Medical Devices

Orthofix Bone Screws for External Fixation System
Risks due to the Re-Use of "Single Use" Device​​​​​​
​ProCallus FixatorOrthofix External Fixation System

Orthofix Fixation System Medical Devices

Orthofix Bone Screws for External Fixation System

Risks due to the Re-Use of "Single Use" Device​​​​​​

​Small DAFOrthofix Self-Aligning Articulated Body (30036) for Small DAF (31000)
Orthofix External Fixation System
Orthofix Fixation System Medical Devices

Risks due to the Re-Use of "Single Use" Device​​​​​​

​TL-HEXOrthofix External Fixation System

Orthofix Fixation System Medical Devices
Orthofix Bone Screws for External Fixation System
Risks due to the Re-Use of "Single Use" Device​​​​​​

Galaxy - TL-HEX Connection System

TL-HEX TrueLok Hexapod System (TL-HEX) External Fixation System
TrueLok External Fixation System
TrueLok External Fixation System TrueLok Screws
TrueLok Wire Tensioner (54-1139)
TrueLok Wire Tensioning and Locking Elements
TrueLok and TL-HEX Dynamization Module (Dynamo)
​TrueLokOrthofix External Fixation System

Orthofix Fixation System Medical Devices
Orthofix Bone Screws for External Fixation System
Risks due to the Re-Use of "Single Use" Device​​​​​​ 

TL-HEX TrueLok Hexapod System (TL-HEX) External Fixation System
TrueLok External Fixation System
TrueLok External Fixation System TrueLok Screws
TrueLok Wire Tensioner (54-1139)​​

TrueLok Wire Tensioning and Locking Elements

TrueLok and TL-HEX Dynamization Module (Dynamo)

​​XWires (Not Sold ​in the U.S.A.)Orthofix External Fixation System

 Spine Fixation Instructions for Use (IFU) for Healthcare Professionals

​​CERVICA​​L


​​​​​​Ascent®​/ Ascent® LECONSTRUX®  Mini PEEK
LONES​TAR®
Reliant®
Azu​re​​CONSTRUX®  Mini ​PTCM6-CArtificial Cervical Disc​​​​3 De​​gree™​
Centurion®​Evolution – C Cervical Implant Removal System ​​M6-C Artificial Cervical Disc Surgical Instruments

CETRAHallmark®​NewBrid​ge®​​

THORACOLUMBAR​


ATHLET​​Firebir​d® 1.0​
​​JANUS® Midline Screw
PILLAR® SA PTC
Connector System ​​​​Firebir​d® 1.0​ – Fo​r International Use Only
JANUS® Midline Screw – For International Use Only
QUADRx® Lateral Retractor
​​​CONSTRUX®  Mini PEEK VBR
FORZA®​ PE​EK
M6-LArtificial Lumbar Disc - For International Use Only

SKYHAWK® Lateral Int​erbody

CONSTRUX®  PEEK VBR
FORZA®​ PTC​​​​
Navigated
SKYHAWK® Lateral Plate
Evolution – TL Thoracolumbar Implant Removal System

FORZA® XP

NGage®
MIS Retractor System
Firebird®/Firebird® NXG
InS​​Wing (Not Sold in the U.S.A.)
Phoenix®/Phoenix® CDX​​​​
StabiLink®​​​​
Firebird®/Firebird® NXG – For International Use Only
ICON
Phoenix®/Phoenix® CDX​​​​ – For International Use OnlyTDX (Not Sold in the U.S.A.)
Firebird® Deformity​​​
JANUS® Fenestrated Screw
PILLAR® AL, PL, TL, XL PEEK
TeDan Hang 10 Midline Retractor
Firebird® Deformity​​​​ – For International Use OnlyJANUS® Fenestrated Screw – For International Use Only
​​PILLAR® SA​​Unity​®​​​​​​​​​


​​​​​​DEFORMITY​​​​


​​MIS​



​INTERBODY DEVICE​


​​​​SI FIXATION​


SambaS​​crew®​​​​​

 Previous Versions

BIOLOGICS

 

Alloquent PLIF/ALIF Allograft Syst​em – Rev A – 21​ Mar 11 - AW-31-9901

Alloquent Cervical Allograft System – Rev AA​ – 22 Jan 13 - AW-30-9901

Alloquent ALIF Allograft System – Rev AB – 22 Jul 11 - AW-32-9903

Trinity Evolution Delivery System– Rev C – 1 Apr 11 – AW-35-9901

Trinity Evolution Strainer Cap – Rev AB – 15 Oct 11 – AW-35-9902

 

BONE GROWTH THERAPIES

 

CervicalStim Device Manual – US – Rev AB – 06 Oct 16 – AW-20115188

CervicalStim Device Manual – US – Rev AC – 30 Jul 18 – AW-20115188

CervicalStim Device Manual – US – Rev AD – 05 Sept 18 – AW-20115188

CervicalStim Device Manual – CA.MX. – Rev AB – 19 Oct 16 – AW-20122318

CervicalStim Device Manual – CA.MX. – Rev AC – 30 Jul 18 – AW-20122318

CervicalStim Device Manual – CA.MX. – Rev AD – 11 Sept 18 – AW-20122318

CervicalStim Device Manual – CE – Rev AB – 19 Oct 16 – AW- 20122316

CervicalStim Device Manual – CE – Rev AC – 22 Aug 17 – AW- 20122316

CervicalStim Device Manual – CE – Rev AD – 30 Jul 18 – AW- 20122316

CervicalStim Device Manual – CE – Rev AE – 11 Sept 18 – AW- 20122316

CervicalStim Device Manual – CE – Rev AF – 1 Jan 19 – AW- 20122316

 

PhysioStim Device Manual – US – Rev AB – 06 Feb 18 – AW- 20123118

PhysioStim Device Manual – US – Rev AC – 26 Apr 18 – AW- 20123118

PhysioStim Device Manual – US – Rev AD – 14 Sept 18 – AW- 20123118

PhysioStim Device Manual – CA.MX. – Rev AA – 25 Jan 18 – AW- 20123490

PhysioStim Device Manual – CA.MX. – Rev AB – 26 Apr 18 – AW- 20123490

PhysioStim Device Manual – CA.MX. – Rev AC – 14 Sept 18 – AW- 20123490

PhysioStim Device Manual – CE – Rev AA – 25 Jan 18 – AW- 20123489

PhysioStim Device Manual – CE – Rev AB – 26 Apr 18 – AW- 20123489

PhysioStim Device Manual – CE – Rev AC – 04 Sept 18 – AW- 20123489

PhysioStim Device Manual – CE – Rev AD – 1 Jan 19 – AW- 20123489

 

SpinalStim Device Manual – US – Rev AB – 06 Oct 16 – AW- 20115189

SpinalStim Device Manual – US – Rev AC – 15 Mar 17 – AW- 20115189

SpinalStim Device Manual – US – Rev AD – 30 Jul 18 – AW- 20115189

SpinalStim Device Manual – CA.MX. – Rev AB – 19 Oct 16 – AW- 20122317

SpinalStim Device Manual – CA.MX. – Rev AC – 30 Jul 18 – AW- 20122317

SpinalStim Device Manual – CA.MX. – Rev AD – 11 Sept 18 – AW- 20122317

SpinalStim Device Manual – CE – Rev AC – 22 Aug 17 – AW- 20122315

SpinalStim Device Manual – CE – Rev AD – 30 Jul 18 – AW- 20122315

SpinalStim Device Manual – CE – Rev AE – 11 Sept 18 – AW- 20122315

SpinalStim Device Manual – CE – Rev AF – 1 Jan 19 – AW- 20122315​

 

SPINAL IMPLANTS

 

3° Anterior Cervical Plating System – Rev AC – Dec 2016 - AW-60-9902

3° Anterior Cervical Plating System – Rev AD – May 2017 - AW-60-9902

 

Ascent and Ascent LE POCT System – Rev BA - Dec 2016 - AW-65-9902

Ascent and Ascent LE POCT System – Rev BB - May 2017 - AW-65-9902​


Centurion POCT System – Rev AD - Sept 2018 - AW-69-9901

 

CETRA Anterior Cervical Plate System – Rev AA – Oct 2016 – AW-19-9901

 

Connector System – Rev AA – Sept 2017 – AW-79-9901

 

CONSTRUX PEEK Vertebral Body Replacement System – Rev AB – Sept 2016 – AW-45-9904


CONSTRUX Mini PTC Spacer System – Rev AE – Oct 2018 – AW-37-9901

 

Firebird Deformity System – Rev CF – May 2018 – AW-44-9902

Firebird Deformity System – Rev CH – Sept 2018 – AW-44-9902

Firebird Deformity System – Rev CL – Feb 2019 – AW-44-9902


Firebird Deformity System – Rev AA – Aug 2018 – AW-36-9902​ - For International Use Only

Firebird Deformity System – Rev AB – Sept 2018 – AW-36-9902​​ - For International Use Only

Firebird Deformity System – Rev AC – Feb 2019 – AW-36-9902​​ - For International Use Only


Firebird NXG System – Rev CD – Dec 2016 – AW-44-9902

Firebird NXG System – Rev CE – May 2017 – AW-44-9902

Firebird NXG System – Rev CF – May 2018 – AW-44-9902

Firebird NXG System – Rev CG – Aug 2018 – AW-44-9902

Firebird NXG System – Rev CH – Sept 2018 – AW-44-9902

Firebird NXG System – Rev CL – Feb 2019 – AW-44-9902

 

Firebird NXG System – Rev AA – Aug 2018 – AW-36-9902​ - For International Use Only

Firebird NXG System – Rev AB – Sept 2018 – AW-36-9902​​ - For International Use Only

Firebird NXG System – Rev AC – Feb 2019 – AW-36-9902​​ - For International Use Only


Firebird Spinal Fixation System – Rev CD – Dec 2016 – AW-44-9902

Firebird Spinal Fixation System – Rev CE – May 2017 – AW-44-9902

Firebird Spinal Fixation System – Rev CF – May 2018 – AW-44-9902

Firebird Spinal Fixation System – Rev CG – Aug 2018 – AW-44-9902

Firebird Spinal Fixation System – Rev CH – Sept 2018 – AW-44-9902

Firebird Spinal Fixation System – Rev CL – Feb 2019 – AW-44-9902


Firebird Spinal Fixation System – Rev AA – Aug 2018 – AW-36-9902​ - For International Use Only

Firebird Spinal Fixation System – Rev AB – Sept 2018 – AW-36-9902​​ - For International Use Only

Firebird Spinal Fixation System – Rev AC – Feb 2019 – AW-36-9902​​ - For International Use Only

 

FORZA Spacer System – Intervertebral Body Fusion Device – Rev AD – Jan 2017 – AW-89-9901

FORZA Spacer System – Intervertebral Body Fusion Device – Rev AE – Oct 2018 – AW-89-9901

 

FORZA PTC Spacer System – Rev AB – Jan 2017 – AW-38-9901

FORZA PTC Spacer System – Rev AC – Oct 2018 – AW-38-9901

 

FORZA XP Expandable Spacer System – Rev AA – Sept 2017 – AW-28-9901

FORZA XP Expandable Spacer System – Rev AC – Sept 2018 – AW-28-9901​

FORZA XP Expandable Spacer System – Rev AD – Aug 2019 – AW-28-9901​

 

Hallmark Anterior Cervical Plate System – Rev AC – Dec 2016 – AW-62-9903

 

InSWing Interspinous Spacer – Rev AA – Dec 2016 – AW-17-9902

 

JANUS Fenestrated Screw - Rev CF – May 2018 – AW-44-9902

JANUS Fenestrated Screw – Rev CH – Sept 2018 – AW-44-9902

JANUS Fenestrated Screw – Rev CL – Feb 2019 – AW-44-9902


JANUS Fenestrated System – Rev AA – Aug 2018 – AW-36-9902​ - For International Use Only

JANUS Fenestrated  System – Rev AB – Sept 2018 – AW-36-9902​​ - For International Use Only

JANUS Fenestrated System – Rev AC – Feb 2019 – AW-36-9902​​ - For International Use Only

 

JANUS Midline Fixation Screw – Rev CD – Dec 2016 – AW-44-9902

JANUS Midline Fixation Screw – Rev CE – May 2017 – AW-44-9902

JANUS Midline Fixation Screw – Rev CF – May 2018 – AW-44-9902

JANUS Midline Fixation Screw – Rev CG – Aug 2018 – AW-44-9902

JANUS Midline Fixation Screw – Rev CH – Sept 2018 – AW-44-9902

JANUS Midline Fixation Screw – Rev CL – Feb 2019 – AW-44-9902

 

JANUS Midline Fixation System – Rev AA – Aug 2018 – AW-36-9902​ - For International Use Only

JANUS Midline Fixation  System – Rev AB – Sept 2018 – AW-36-9902​​ - For International Use Only

JANUS Midline Fixation ​System – Rev AC – Feb 2019 – AW-36-9902​​ - For International Use Only


LONESTAR Cervical Stand Alone System – Rev AC – Dec 2016 – AW-83-9901

LONESTAR Cervical Stand Alone System – Rev AD – Oct 2018 – AW-83-9901


Navigated Instrument System - Rev AF - Oct 2018 - AW-36-9901

 

NewBridge Laminoplasty Fixation System – Interlaminal Fixation Appliance – Rev AA – Dec 2016 – AW-40-9902

NewBridge Laminoplasty Fixation System – Interlaminal Fixation Appliance – Rev AB – May 2017 – AW-40-9902

 

Phoenix CDX Minimally Invasive Spinal Fixation System - Rev CD – Dec 2016 – AW-44-9902

Phoenix CDX Minimally Invasive Spinal Fixation System – Rev CE – May 2017 – AW-44-9902

Phoenix CDX Minimally Invasive Spinal Fixation System – Rev CF – May 2018 – AW-44-9902

Phoenix CDX Minimally Invasive Spinal Fixation System – Rev CG – Aug 2018 – AW-44-9902

Phoenix CDX Minimally Invasive Spinal Fixation System – Rev CH – Sept 2018 – AW-44-9902

Phoenix CDX Minimally Invasive Spinal Fixation System – Rev CL – Feb 2019 – AW-44-9902

 

Phoenix CDX Minimally Invasive Spinal Fixation System – Rev AA – Aug 2018 – AW-36-9902​ - For International Use Only

Phoenix CDX Minimally Invasive Spinal Fixation System – Rev AB – Sept 2018 – AW-36-9902​​ - For International Use Only

Phoenix CDX Minimally Invasive Spinal Fixation System – Rev AC – Feb 2019 – AW-36-9902​​ - For International Use Only


Phoenix Minimally Invasive Spinal Fixation System - Rev CD – Dec 2016 – AW-44-9902

Phoenix Minimally Invasive Spinal Fixation System – Rev CE – May 2017 – AW-44-9902

Phoenix Minimally Invasive Spinal Fixation System – Rev CF – May 2018 – AW-44-9902

Phoenix Minimally Invasive Spinal Fixation System – Rev CG – Aug 2018 – AW-44-9902

Phoenix Minimally Invasive Spinal Fixation System – Rev CH – Sept 2018 – AW-44-9902

Phoenix Minimally Invasive Spinal Fixation System – Rev CL – Feb 2019 – AW-44-9902

 

Phoenix Minimally Invasive Spinal Fixation System – Rev AA – Aug 2018 – AW-36-9902​ - For International Use Only

Phoenix Minimally Invasive Spinal Fixation System – Rev AB – Sept 2018 – AW-36-9902​​ - For International Use Only

Phoenix Minimally Invasive Spinal Fixation System​ – Rev AC – Feb 2019 – AW-36-9902​​ - For International Use Only


PILLAR PEEK Spacer System – Rev AB – Jan 2017 – AW-72-9902

PILLAR PEEK Spacer System – Rev AC – May 2017 – AW-72-9902

 

PILLAR SA PEEK Spacer System – Rev AB – Jan 2017 – AW-49-9902

 

PILLAR SA PTC Spacer System – Rev AA – Aug 2016 – AW-39-9901

 

Proview Minimal Access Portal (MAP) System – Rev AA – Jan 2017 – AW-70-9906

 

SambaScrew SI Fixation System – Rev AA – Sept 2016 – AW-11-9901

 

SKYHAWK Lateral Interbody Fusion System – Rev AB – Jan 2017 – AW-27-9901

 

TDX Posterior Dynamic Stabilization System – Rev BC – Dec 2016 – AW-16-9901