510(k) Report

Devices descending from K841189

2,425 later devices reach Oec/Rezaian Spinal Fixator through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+5K160051NuVasive® Interfixated Interbody SystemNu Vasive, Incorporated2016396—
+5K160124LUMIS Cannulated Pedicle Screw Fixation System, U.L.I.S. Pedicle Screw Fixation SystemSpinevision S.A.20162—
+5K153495Avenue L Lateral Lumbar Cage, Avenue T TLIF Cage System, ROI-A ALIF Cage System, ROI-T…Ldr Spine USA20161891
+5K152200SurgTech Interbody SystemSurgtech, Inc.20160—
+5K153782NuVasive® Lumbar Interbody ImplantsNu Vasive, Incorporated2016390—
+5K160547Cascadia Interbody SystemK2m2016157—
+5K153627NuVasive® TLX Interbody SystemNu Vasive, Incorporated2016252—
+5K151665SUSTAIN Additional ImplantsGlobus Medical, Inc.2016119—
+5K160002Piccolo Composite (R) Distal Volar Radius Plate SystemCarboFix Orthopedics, Ltd.20164—
+5K153438PERIMETER C (Titanium) Spinal SystemMedtronic Sofamor Danek USA, Inc.20160—
+5K153442CD HORIZON Spinal System, Medtronic Navigated Manual Reusable Instruments for Use with…Medtronic Sofamor Danek USA, Inc.201684—
+5K152781Adena-Zina SystemShanghai Sanyou Medical Co, Ltd.20165—
+5K153203Navigation InstrumentsGlobus Medical, Inc.2016112—
+5K152793Unison-C Anterior Cervical Fixation SystemPioneer Surgical Technology, Inc., Dba Rti Surgical, Inc.201629—
+5K153373CORNERSTONE PSR Cervical Fusion System, PERIMETER C Spinal System, PEEK PREVAIL Cervical…Medtronic Sofamor Danek2016110—
+5K153356Spine Innovation Interbody SystemSpine Innovation, LLC20161—
+5K153536Piccolo Composite® Nailing SystemCarboFix Orthopedics, Ltd.201611
+5K152604KYPHON HV-R Fenestrated Screw Cement, CD HORIZON Fenestrated Screw SetMedtronic Sofamor Danek USA, Incorporated2016159—
+5K152968Arsenal Spinal Fixation SystemAlphatec Spine, Inc.201583—
+5K152532AERO -C Cervical Cage SystemStryker Spine2015145—
+5K152515TOMCAT Cervical Spinal SystemChoicespine, LP2015108—
+5K151770Libra Pedicle Screw SystemSpinal Balance, Inc.20151—
+5K152259InFill Interbody Fusion DevicePinnacle Spine Group, LLC20152—
+5K152277PIVOX (tm) Oblique Lateral Spinal SystemMedtronic Sofamor Danek USA, Inc.2015190—
+5K151819Integrity Spine Lumbar Interbody Fusion SystemIntegrity Spine Lumbar Interbody Fusion System20154—
+5K152248CD HORIZON Spinal SystemMedtronic Sofamor Danek USA, Inc.20150—
+5K152457CD HORIZON Spinal SystemMedtronic Sofamor Danek USA, Inc.2015145—
+5K152131Reliance Spinal Screw SystemReliance Medical Systems, LLC20154—
+5K151472NuVasive CoRoent Lumbar SystemNu Vasive, Incorporated2015479—
+5K151322Amendia Interbody Fusion DevicesAmendia, Inc.20152261
+5K150812Genesys Spine Apache Cervical Interbody Fusion SystemGenesys Spine201512—
+5K150673SYNFIX Evolution Secured Spacer SystemSynthes (USA) Products, LLC2015137—
+5K151756Sterispine LC CageSafe Orthopaedics20150—
+5K150481Cascadia Interbody SystemK2m, Inc.20154593
+5K151140LnK Lumbar Interbody Fusion Cage SystemL&K BIOMED Co., Ltd.201529—
+5K151654Prow FusionNlt Spine, Ltd.20151—
+5K151196Nautilus Spinal SystemLife Spine, Inc.201512—
+5K150321EVOS Lumbar Interbody SystemCutting Edge Spine, LLC201592—
+5K150994NuVasive CoRoent Thoracolumbar ImplantsNu Vasive, Incorporated2015402—
+5K150135DIVERGENCE-L Anterior/Oblique Lumbar Fusion SystemMedtronic Sofamor Danek USA, Inc.2015228—
+5K143572Intersomatic Cervical Device - DICOM PEEK, Intersomatic Intervertebral Space Maintenance…Osteomed Implantes, Ltda20150—
+5K151215Mercury Spinal SystemSpinal Elements, Inc.20158—
+5K143496Piccolo Composite Plate SystemCarboFix Orthopedics, Ltd.20154—
+5K142487Chesapeake Stabilization SystemK2m, Inc.201571
+5K142744Mecta-C TiPEEKMedacta International201512—
+5K143595NuVasive (R) CCX-L Interbody SystemNu Vasive, Incorporated2015253—
+5K140348Interbody CageEisertech, LLC2015235—
+5K143684NuVasive Reline SystemNu Vasive, Incorporated201577—
+5K142634Biomet Spine Fusion SystemBiomet Spine, LLC20155—
+5K143214SCARLET® AC-T Secured Anterior Cervical CageSpineart20153—
+5K141798Sypher Spacer SystemBiogennix, LLC20151—
+5K150178CD Horizon Spinal SystemMedtronic Sofamor Danek USA, Inc.201525—
+5K142940Endoskeleton TCS SystemTitan Spine, LLC20151112
+5K143163AVS® AL and ALign PEEK Spacers, AVS® PL and UniLIF PEEK Spacers, AVS® TL PEEK Spacer…Stryker Corporation2015636—
+5K141599Divergence Anterior Cervical Fusion SystemMedtronic Sofamor Danek USA, Inc.201516—
+5K142360Everest Spinal SystemK2m, Inc.201522—
+5K141253New Era Orthopaedics Polyscrew Pedicle Screw SystemNew Era Orthopaedics, LLC201511
+5K142152Construx Mini Peek; Spacer System, TI Spacer System, Cervical Stand Alone SystemOrthofix, Inc.2015280—
+5K142328nvcNvision Biomedical Technologies, LLC20144—
+5K142737MAS PLIF Fixation systemNu Vasive, Incorporated20141—
+5K143141CD HORIZON Spinal SystemMedtronic Sofamor Danek USA, Inc.201416—
+5K142594nva, nvp, nvtNvision Biomedical Technologies, LLC20144—
+5K141333Arena-C Tifuse Cervical Intervertebral Body Fusion DeviceSpinefrontier, Inc.20140—
+5K142023Luna Interbody SystemBenvenue Medical, Inc.20145—
+5K142499Reline SystemNu Vasive, Incorporated201478—
+5K142066Aero-LL Lumbar Cage SystemStryker Corporation20142—
+5K141942Midline II TICentinel Spine, Inc.2014459—
+5K142150Ais Modulift VBR SystemAesculap Implant System, Inc.201447—
+5K142847CD HORIZON Spinal SystemMedtronic Sofamor Danck USA, Inc.2014286—
+5K142026Spinefrontier Arena-C HA Peek Cervical Intervertebral Body Fusion DeviceSpinefrontier, Inc.2014190—
+5K142277Juliet POSpineart2014119—
+5K141314Scarlet AC-T Secured Anterior Cervical Cage and Associated InstrumentationSpineart201438—
+5K141337Arena-CSpinefrontier, Inc.20141—
+5K141372Mercury Spinal SystemSpinal Elements, Inc.20149—
+5K141129Exactech Cervical Spacer SystemExactech, Inc.20148—
+5K141005Z-Link CervicalZavation, LLC20144—
+5K140479Coroent XL-F SystemNu Vasive, Incorporated2014465—
+5K140770MLX - Medial Lateral Expandable Lumbar Interbody SystemNu Vasive, Incorporated2014269—
+5K140864Veloxtm Interbody Fusion SystemU&I Corp.20149—
+5K141605CD Horizon Spinal SystemMedtronic Sofamor Danek USA, Inc.2014210—
+5K140417Divergence Mini-Plate Anterior Cervical Fusion SystemMedtronic Sofamor Danek, Inc.201411—
+5K140162AP Expandable Xlif SystemNuvasive, Inc.2014236—
+5K133575Spinevision Lumis Cannulated Pedicle Screw Fixation System, Spinevision U.L.I.S. Pedicle…Spinevision S.A.20143—
+5K133494Chesapeake Spinal SystemK2m, Inc.2014330—
+5K141147Range Spinal SystemK2m, Inc.20141—
+5K140529Everest Spinal SystemK2m, LLC201431—
+5K140010Fortress Pedicle Screw SystemSpineology, Inc.201411—
+5K140474Juliet OLSpineart2014120—
+5K133815Intess Cervical Cage SystemKalitec Direct, LLC20144—
+5K132999Cervical Stand Alone SystemOrthofix, Inc.2014281—
+5K133340Spineworks Anterior Lumbar DeviceSpineworks, LLC201413—
+5K133743Baxano Surgical Mis Spinal SystemBaxano Surgical, Inc.20140—
+5K133614Aleutian Ibf SystemK2m, Inc.2014527—
+5K140003Coroent Small Interbody SystemNuvasive, Inc.2014453—
+5K133721Infill 41-Tlif Convex Oblique Device, Infill 43-Tlif Contour Oblique, Infill 44-Tlif…Pinnacle Spine Group, LLC20145—
+5K133205Capstone PTC Spinal System, Clydesdale PTC Spinal SystemMedtronic Sofamor Danek USA, Inc.2014124—
+5K140276CD Horizon Spinal SystemMedtronic Sofamor Danek201485—
+5K133746Polaris Spinal SystemBiomet Spine (Aka Ebi, LLC)2014671
+5K132926Velofixtm Interbody Fusion SystemU&I Corp.201410—
+5K133564Modification to Nautilus Spinal SystemLife Spine, LLC201413—