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Interbody DeviceInterbody Device
3/31/2017 10:04 AMSystem Account
NoSKYHAWK® Lateral Interbody Fusion SystemApproved
  
ThoracolumbarThoracolumbar
3/31/2017 10:03 AMSystem Account
NoFORZA® PTC Spacer SystemApproved
  
Interbody DeviceInterbody Device
3/31/2017 10:02 AMSystem Account
NoFORZA® PTC Spacer SystemApproved
  
9/8/2016 11:22 AMSystem Account
NoDistributor OpportunitiesApproved
  
8/23/2016 9:08 AMSystem AccountJohn BurdenNoUDI SearchApproved
  
ThoracolumbarThoracolumbar
12/16/2016 9:27 AMDeni Stoyanova
NoPILLAR® SA PTC Spacer System Approved
  
ThoracolumbarThoracolumbar
6/16/2017 10:51 AMLesley Webster
NoFirebird® NXG Spinal Fixation SystemApprovedApproved
  
Interbody DeviceInterbody Device
12/16/2016 9:27 AMDeni Stoyanova
NoPILLAR® SA PTC Spacer System Approved
  
9/12/2016 2:06 PMSystem Account
Orthofix Products0Approved
  
9/12/2016 2:08 PMSystem Account
Spine Fixation0Approved
  
Extremity Fixation
5/17/2017 2:21 PMSystem Account
Extremity Fixation0ApprovedApproved
  
Biologic
5/15/2017 2:53 PMSystem Account
Biologics0ApprovedApproved
  
Biostim
6/26/2014 11:03 AMDeni StoyanovaLesley WebsterBioStim0Approved
  
Cervical
6/26/2014 11:04 AMDeni Stoyanova
NoOrthofix Cervical Products0Approved
  
Thoracolumbar
10/14/2014 4:25 PMDeni Stoyanova
NoOrthofix Thoracolumbar Products0Approved
  
MIS
6/26/2014 11:04 AMDeni Stoyanova
NoOrthofix MIS Products0Approved
  
Deformity
6/26/2014 11:04 AMDeni Stoyanova
NoOrthofix Deformity Products0Approved
  
SI Fixation
6/26/2014 11:04 AMDeni Stoyanova
NoOrthofix SI Fixation Products0Approved
  
Upper Extremity
11/4/2016 1:54 PMSystem Account
NoOrthofix Upper Extremity Products0Approved
  
Lower Extremity
4/17/2017 10:47 AMSystem Account
NoOrthofix Lower Extremity Products0Approved
  
Pediatrics
6/8/2017 9:50 AMSystem Account
NoOrthofix Pediatric Products0ApprovedApproved
  
Interbody Device
6/26/2014 11:04 AMDeni Stoyanova
NoOrthofix Interbody Device Products0Approved
  
CervicalCervical
6/23/2016 1:31 PMSystem Account
NoCenturion® POCT System 1.1.01Approved
  
CervicalCervical
6/23/2016 1:17 PMSystem Account
NoLONESTAR® Cervical Stand Alone (CSA)1.1.02Approved
  
CervicalCervical
3/31/2017 10:03 AMSystem Account
NoCONSTRUX® Mini PTC Spacer System1.1.04Approved
  
CervicalCervical
3/21/2016 5:04 PMBlake Burnham
NoHallmark® Anterior Cervical Plate (ACP) System1.1.05Approved
  
CervicalCervical
5/1/2017 11:53 AMSystem Account
NoReliant® Anterior Cervical Plating (ACP) System1.1.06ApprovedApproved
  
CervicalCervical
3/20/2017 11:55 AMSystem Account
NoCONSTRUX® Mini PEEK Spacer System1.1.07Approved
  
CervicalCervical
3/21/2016 5:06 PMBlake Burnham
NoNewBridge® Laminoplasty Fixation System1.1.08Approved
  
CervicalCervical
3/21/2016 5:06 PMBlake Burnham
NoAscent® LE Posterior Occipital Cervico-Thoracic System1.1.09Approved
  
CervicalCervical
8/15/2016 4:55 PMSystem Account
No3° ™ Anterior Cervical Plating (ACP) System1.1.10Approved
  
ThoracolumbarThoracolumbar
6/6/2016 11:13 AMDeni StoyanovaDeni StoyanovaNoFirebird® Spinal Fixation System1.2.01Approved
  
ThoracolumbarThoracolumbar
6/6/2016 11:15 AMDeni Stoyanova
NoJANUS® Midline Fixation Screw1.2.02Approved
  
ThoracolumbarThoracolumbar
3/21/2016 5:10 PMBlake Burnham
NoSKYHAWK® Lateral Interbody Fusion System & Lateral Plate System1.2.03Approved
  
ThoracolumbarThoracolumbar
3/21/2016 5:10 PMBlake Burnham
NoPhoenix® CDX™1.2.04Approved
  
ThoracolumbarThoracolumbar
6/6/2016 11:32 AMBlake Burnham
NoFirebird® Deformity Correction System1.2.05Approved
  
ThoracolumbarThoracolumbar
6/6/2016 11:31 AMBlake Burnham
NoPHOENIX® Minimally Invasive Spinal Fixation System1.2.06Approved
  
ThoracolumbarThoracolumbar
3/21/2016 5:14 PMBlake Burnham
NoFORZA®​ PEEK Spacer System1.2.07Approved
  
ThoracolumbarThoracolumbar
3/21/2016 5:14 PMBlake Burnham
NoPILLAR® SA PEEK Spacer System1.2.08Approved
  
ThoracolumbarThoracolumbar
3/21/2016 5:14 PMBlake Burnham
NoNGage® Surgical Mesh System1.2.09Approved
  
ThoracolumbarThoracolumbar
3/21/2016 5:15 PMBlake Burnham
YesInSWing™1.2.10Approved
  
ThoracolumbarThoracolumbar
3/21/2016 5:15 PMBlake Burnham
YesTDX™ Posterior Dynamic Stabilization 1.2.11Approved
  
ThoracolumbarThoracolumbar
3/21/2016 5:17 PMBlake Burnham
NoPILLAR® AL PEEK Spacer System1.2.12Approved
  
ThoracolumbarThoracolumbar
3/21/2016 5:17 PMBlake Burnham
NoPILLAR® PL and TL PEEK Spacer System1.2.13Approved
  
ThoracolumbarThoracolumbar
3/21/2016 5:17 PMBlake Burnham
NoUnity® Lumbosacral Fixation System1.2.14Approved
  
ThoracolumbarThoracolumbar
5/2/2016 5:06 PMBlake Burnham
NoSpinal Fixation System (SFS)1.2.15Approved
  
ThoracolumbarThoracolumbar
11/9/2015 2:08 PMDeni Stoyanova
NoATHLET™1.2.16Approved
  
DeformityDeformity
6/6/2016 11:33 AMBlake Burnham
NoFirebird® Deformity Correction System1.3.1Approved
  
DeformityDeformity
3/21/2016 5:18 PMBlake Burnham
NoPSO Instrument Set1.3.2Approved
  
MISMIS
3/21/2016 5:18 PMBlake Burnham
NoPhoenix® CDX™1.4.01Approved
  
MISMIS
6/6/2016 11:32 AMBlake Burnham
NoPHOENIX® Minimally Invasive Spinal Fixation System1.4.02Approved
  
MISMIS
3/21/2016 5:18 PMBlake Burnham
NoProView® MAP System1.4.03Approved
  
Interbody DeviceInterbody Device
3/21/2016 5:20 PMBlake Burnham
NoFORZA® PEEK Spacer System1.5.01Approved
  
Interbody DeviceInterbody Device
3/31/2017 11:33 AMSystem Account
NoCONSTRUX® Mini PTC Spacer System1.5.02Approved
  
Interbody DeviceInterbody Device
6/23/2016 1:30 PMSystem Account
NoLONESTAR® Cervical Stand Alone (CSA)1.5.03Approved
  
Interbody DeviceInterbody Device
3/21/2016 5:20 PMBlake Burnham
NoPILLAR® SA PEEK Spacer System1.5.04Approved
  
Interbody DeviceInterbody Device
3/20/2017 11:54 AMSystem Account
NoCONSTRUX® Mini PEEK Spacer System1.5.05Approved
  
Interbody DeviceInterbody Device
3/21/2016 5:21 PMBlake Burnham
NoPILLAR® AL PEEK Spacer System1.5.06Approved
  
Interbody DeviceInterbody Device
3/21/2016 5:21 PMBlake Burnham
NoPILLAR® PL and TL PEEK Spacer System1.5.07Approved
  
SI FixationSI Fixation
10/31/2016 9:53 AMSystem Account
NoSambaScrew®​1.6.1Approved
  
Upper ExtremityUpper Extremity
6/6/2017 11:41 AMSystem Account
NoGALAXY™ Fixation2.1.01ApprovedApproved
  
Upper ExtremityUpper Extremity
5/3/2017 10:42 AMSystem Account
NoGALAXY Wrist2.1.02ApprovedApproved
  
Upper ExtremityUpper Extremity
5/3/2017 10:42 AMSystem Account
NoContours VPS®-32.1.03ApprovedApproved
  
Upper ExtremityUpper Extremity
5/3/2017 10:36 AMSystem Account
NoContours PHP2.1.04ApprovedApproved
  
Upper ExtremityUpper Extremity
5/3/2017 10:41 AMSystem Account
NoCentronail Titanium Humeral Nail2.1.05ApprovedApproved
  
Upper ExtremityUpper Extremity
5/3/2017 10:41 AMSystem Account
NoRadioLucent Wrist Fixator2.1.06ApprovedApproved
  
Upper ExtremityUpper Extremity
5/3/2017 10:40 AMSystem Account
NoPennig Minifixator2.1.07ApprovedApproved
  
Upper ExtremityUpper Extremity
5/3/2017 10:40 AMSystem Account
NoMiniRail System2.1.08ApprovedApproved
  
Upper ExtremityUpper Extremity
5/3/2017 10:40 AMSystem Account
NoFragment Fixation System (FFS)2.1.09ApprovedApproved
  
Upper ExtremityUpper Extremity
5/3/2017 10:39 AMSystem Account
NoElbow Fixator2.1.10ApprovedApproved
  
Upper ExtremityUpper Extremity
5/3/2017 10:39 AMSystem Account
NoContours VPS® Volar Plate2.1.11ApprovedApproved
  
Upper ExtremityUpper Extremity
5/3/2017 10:38 AMSystem Account
NoXCaliber® Meta-Diaphyseal Fixator2.1.12ApprovedApproved
  
Upper ExtremityUpper Extremity
5/3/2017 10:38 AMSystem Account
NoProCallus Fixator2.1.13ApprovedApproved
  
Upper ExtremityUpper Extremity
5/3/2017 10:38 AMSystem Account
NoPennig Dynamic Wrist Fixator2.1.14ApprovedApproved
  
Upper ExtremityUpper Extremity
5/3/2017 10:37 AMSystem Account
NoXWires2.1.15ApprovedApproved
  
Upper ExtremityUpper Extremity
5/3/2017 10:37 AMSystem Account
NoFlexible Reamers2.1.16ApprovedApproved
  
Upper ExtremityUpper Extremity
5/3/2017 10:37 AMSystem Account
NoBone Screws2.1.17ApprovedApproved
  
Lower ExtremityLower Extremity
6/6/2017 11:40 AMSystem Account
NoTL-HEX2.2.01ApprovedApproved
  
Lower ExtremityLower Extremity
4/7/2016 4:06 PMBlake BurnhamDeni StoyanovaNoGalaxy UNYCO2.2.01Approved
  
Lower ExtremityLower Extremity
6/5/2017 9:02 AMSystem Account
NoTrueLok Ring Fixation System2.2.02ApprovedApproved
  
Lower ExtremityLower Extremity
5/3/2017 10:29 AMSystem Account
NoContours LPS (Lapidus Plating System)2.2.04ApprovedApproved
  
Lower ExtremityLower Extremity
6/6/2017 11:40 AMSystem Account
NoGALAXY™ Fixation2.2.05ApprovedApproved
  
Lower ExtremityLower Extremity
5/3/2017 10:28 AMSystem Account
NoAnkle Compression Nail (ACN)2.2.06ApprovedApproved
  
Lower ExtremityLower Extremity
11/4/2016 2:05 PMSystem AccountAndrea FornalèNoLRS ADVanced2.2.07Approved
  
Lower ExtremityLower Extremity
5/2/2017 9:24 AMSystem Account
YesISKD (Intramedullary Skeletal Kinetic Distractor) 2.2.08ApprovedApproved
  
Lower ExtremityLower Extremity
5/3/2017 10:28 AMSystem Account
NoCalcaneal Minifixator2.2.09ApprovedApproved
  
Upper ExtremityUpper Extremity
5/3/2017 10:36 AMSystem Account
NoOSCAR32.2.09ApprovedApproved
  
Lower ExtremityLower Extremity
5/3/2017 10:27 AMSystem Account
NoOSCAR32.2.09ApprovedApproved
  
Lower ExtremityLower Extremity
5/3/2017 10:28 AMSystem Account
NoMiniRail System2.2.10ApprovedApproved
  
Lower ExtremityLower Extremity
5/3/2017 10:27 AMSystem Account
NoPennig Minifixator2.2.11ApprovedApproved
  
Lower ExtremityLower Extremity
5/3/2017 10:26 AMSystem Account
NoXCaliber® Hybrid Fixator2.2.12ApprovedApproved
  
Lower ExtremityLower Extremity
5/3/2017 10:26 AMSystem Account
NoXCaliber® Meta-Diaphyseal Fixator2.2.13ApprovedApproved
  
Lower ExtremityLower Extremity
5/3/2017 10:25 AMSystem Account
NoXCaliber® Articulated Ankle Fixator2.2.14ApprovedApproved
  
Lower ExtremityLower Extremity
5/3/2017 10:25 AMSystem Account
YesPrefix 22.2.15ApprovedApproved
  
Lower ExtremityLower Extremity
5/3/2017 10:24 AMSystem Account
NoSheffield Ring Fixator2.2.15ApprovedApproved
  
Lower ExtremityLower Extremity
5/3/2017 10:24 AMSystem Account
NoProCallus Fixator2.2.17ApprovedApproved
  
Lower ExtremityLower Extremity
5/3/2017 10:23 AMSystem Account
NoCentronail Titanium Tibial Nail2.2.18ApprovedApproved
  
Lower ExtremityLower Extremity
5/3/2017 10:23 AMSystem Account
NoCentronail Titanium Femoral Nail2.2.19ApprovedApproved
  
Lower ExtremityLower Extremity
5/3/2017 10:23 AMSystem Account
NoCentronail Titanium Supracondylar and Retrograde Nail2.2.20ApprovedApproved
  
Lower ExtremityLower Extremity
5/3/2017 10:22 AMSystem Account
NoVeronail Titanium Trochanteric Nail2.2.21ApprovedApproved
  
Lower ExtremityLower Extremity
5/3/2017 10:22 AMSystem Account
NoStainless Steel Antegrade Nails2.2.22ApprovedApproved
  
Lower ExtremityLower Extremity
5/3/2017 10:22 AMSystem Account
NoRetronail - Ankle Arthrodesis2.2.23ApprovedApproved
  
Lower ExtremityLower Extremity
5/3/2017 10:21 AMSystem Account
NoPertrochanteric Fixator2.2.24ApprovedApproved
  
Lower ExtremityLower Extremity
5/3/2017 10:21 AMSystem Account
NoPelvic Fixator2.2.25ApprovedApproved
  
Lower ExtremityLower Extremity
5/3/2017 10:21 AMSystem Account
NoGotfried PC.C.P.2.2.26ApprovedApproved
  
Lower ExtremityLower Extremity
5/3/2017 10:20 AMSystem Account
NoPORD Device2.2.27ApprovedApproved
  
Lower ExtremityLower Extremity
5/3/2017 10:20 AMSystem Account
NoFragment Fixation System (FFS)2.2.28ApprovedApproved
  
Lower ExtremityLower Extremity
5/3/2017 10:20 AMSystem Account
NoBone Screws2.2.29ApprovedApproved
  
Lower ExtremityLower Extremity
5/3/2017 10:19 AMSystem Account
NoFlexible Reamers2.2.30ApprovedApproved
  
Lower ExtremityLower Extremity
5/3/2017 10:19 AMSystem Account
NoXWires2.2.31ApprovedApproved
  
Lower ExtremityLower Extremity
5/3/2017 10:18 AMSystem Account
NoAHN2.2.31ApprovedApproved
  
PediatricsPediatrics
6/9/2017 11:18 AMSystem Account
Noeight-Plate Plus2.3.01ApprovedApproved
  
PediatricsPediatrics
6/9/2017 11:17 AMSystem Account
NoTL-HEX™2.3.02ApprovedApproved
  
6/9/2017 11:16 AMSystem Account
NoTrueLok Ring Fixation System2.3.03ApprovedApproved
  
PediatricsPediatrics
6/9/2017 11:16 AMSystem Account
NoLRS Pediatric2.3.04ApprovedApproved
  
6/12/2017 9:14 AMSystem Account
NoGALAXY™ Fixation2.3.05ApprovedApproved
  
PediatricsPediatrics
6/9/2017 11:17 AMSystem Account
NoSmall DAF2.3.06ApprovedApproved
  
6/9/2017 11:16 AMSystem Account
NoProCallus Fixator2.3.07ApprovedApproved
  
6/9/2017 11:15 AMSystem Account
NoPennig Minifixator2.3.08ApprovedApproved
  
6/9/2017 11:15 AMSystem Account
NoM2 Multiplanar MiniRail2.3.09ApprovedApproved
  
6/9/2017 11:14 AMSystem Account
NoPennig Dynamic Wrist Fixator2.3.10ApprovedApproved
  
PediatricsPediatrics
6/8/2017 9:48 AMAndrea Fornalè
NoAGILE NAIL™2.3.10ApprovedApproved
  
6/9/2017 10:23 AMSystem Account
NoBone Screws2.3.11ApprovedApproved
  
PediatricsPediatrics
6/8/2017 9:48 AMAndrea Fornalè
NoMJ-FLEX™2.3.11ApprovedApproved
  
6/9/2017 10:23 AMSystem Account
NoFragment Fixation System (FFS)2.3.12ApprovedApproved
  
PediatricsPediatrics
6/8/2017 9:47 AMAndrea Fornalè
NoGALAXY™ Fixation2.3.12ApprovedApproved
  
6/9/2017 10:22 AMSystem Account
NoXWires2.3.13ApprovedApproved
  
BiologicBiologic
6/19/2017 4:01 PMSystem Account
NoTrinity ELITE®3.1ApprovedApproved
  
BiologicBiologic
3/21/2016 5:01 PMBlake Burnham
NoTrinity Evolution®3.2Approved
  
BiologicBiologic
3/21/2016 5:01 PMBlake Burnham
NoVersaShield®3.3Approved
  
BiologicBiologic
3/21/2016 5:02 PMBlake Burnham
NoCollage® Osteoconductive Scaffold​3.4Approved
  
BiologicBiologic
3/21/2016 5:02 PMBlake Burnham
NoAlloQuent® Structural Allograft3.5Approved
  
BiostimBiostim
6/22/2016 1:21 PMSystem AccountLesley WebsterNoCervical-Stim® Osteogenesis Stimulator4.1Approved
  
BiostimBiostim
6/22/2016 1:21 PMSystem AccountLesley WebsterNoSpinal-Stim® Osteogenesis Stimulator4.2Approved
  
BiostimBiostim
9/12/2016 2:05 PMSystem Account
NoPhysio-Stim® Osteogenesis Stimulator4.3Approved
  
5/5/2014 4:36 PMDeni Stoyanova
No97Approved