510(k) Report

Devices descending from K012254

2,058 later devices reach VBR through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+5K180814CoreLink® M3™ Stand-Alone Anterior Lumbar SystemCorelink, LLC201818—
+5K180556Corelink Foundation 3D Anterior Lumbar SystemCorelink, LLC20185—
+5K173947Lumbar Interbody Fusion System (OLLIF)Advanced Research Medical, LLC201801
+5K181030Rubicon Lumbar Interbody Fusion SystemRubicon Spine, LLC20180—
+5K173832InTice™-C Porous Ti Cervical Interbody SystemX-Spine Systems, Inc.201801
+5K172166OLYMPIC Navigated InstrumentsAstura Medical20185—
+5K172967Mercury® Spinal SystemSpinal Elements, Inc.20185—
+5K180056Genesys Spine AIS-C Cervical Anchored Interbody SystemGenesys Spine201818—
+5K173249CD HORIZON™ Spinal SystemMedtronic Sofamor Danek USA, Inc.20181—
+5K172320Neurostructures Cavetto® Cervical Cage SystemNeurostructures, Inc.20183—
+5K172105The Plateau-LO Spacer SystemLife Spine, Inc.20181—
+5K172185Tyber Medical PT Interbody Spacer SystemTyber Medical, LLC20177—
+5K172330Blustone Synergy Silica SystemBlustone Synergy20170—
+5K173182ProLift® Expandable SystemLife Spine, Inc.201737—
+5K170389TAURUS PEEK Cage SystemMedyssey USA, Inc.20170—
+5K172009Cascadia Interbody SystemK2m, Inc.2017433
+5K173148ACIFColigne AG20171—
+5K163595IMPIX 3D Print CagesMedicrea International SA2017282
+5K172328SOVEREIGN™ Spinal SystemMedtronic Sofamor Danek USA, Inc.201730—
+5K172341NuVasive® Modulus TLIF Interbody SystemNu Vasive, Incorporated2017163—
+5K163366Shanghai Sanyou CARMEN Cervical Fusion SystemShanghai Sanyou Medical Co, Ltd.20170—
+5K170119Calix Lumbar Spinal Implant SystemX-Spine Systems, Inc.201711
+5K171633NuVasive TLX Interbody SystemNu Vasive, Incorporated2017251—
+5K171107CAPSTONE CONTROL Spinal System, CAPSTONE CONTROL PTC Spinal SystemMedtronic Sofamor Danek USA, Inc.20178—
+5K171893Blustone Synergy Lumbar Interbody Fusion System (Basalt, Magma, Obsidian), Blustone…Bluestone Synergy20172—
+5K171321K2M Navigation InstrumentsK2m201711
+5K171140Matrixx SystemNexxt Spine, LLC2017145—
+5K171656Genesys Spine Apache Interbody Fusion SystemGenesys Spine20170—
+5K170844Gemini-C Hybrid Cervical Interbody SystemOsseus Fusion Systems, LLC20170—
+5K170297Tranquil Interbody SystemNexus Spine, LLC201715—
+5K163494Summit Spine Channel Cervical Interbody Fusion SystemSummit Spine20171—
+5K171468FUSE Spinal SystemMedtronic Sofamor Danek20170—
+5K170679CD HORIZON® Spinal System, Medtronic Reusable Instruments for Use with the IPC®…Medtronic Sofamor Danek201786—
+5K163581Navigated ELEVATE Inserter, Navigated Disc Prep InstrumentsMedtronic Sofamor Danek USA, Inc.2017103—
+5K162206Zavation IBFZavation, LLC201724—
+5K170347CD HORIZON™ Fenestrated Screw SetMedtronic Sofamor Danek USA201791—
+5K170243LOSPA IS TLIF & DLIF CagesCorentec Co., Ltd.20170—
+5K163230NuVasive Modulus XLIF Interbody SystemNu Vasive, Incorporated2017276—
+5K163301CD HORIZON® Spinal SystemMedtronic Sofamor Danek USA, Inc.20162—
+5K162680SOVEREIGN® Spinal SystemMedtronic Sofamor Danek USA, Inc.201631—
+5K160222OIC Cervical PEEK SpacerThe Orthopaedic Implant Company20160—
+5K162066Reliance Spinal Screw SystemReliance Medical Systems, LLC20163—
+5K160663Lumbar Interbody Fusion System (ALIF, PLIF, LLIF, TPLIF)Evolution Spine, LLC20160—
+5K162379CD HORIZON® Spinal SystemMedtronic Sofamor Danek USA, Inc.201645—
+5K161438Genesys Spine Apache® Anterior Lumbar Interbody Fusion SystemGenesys Spine201611—
+5K161842Overwatch Spine SystemAmendia, Inc.201661
+5K162494CD HORIZON® Spinal SystemMedtronic Sofamor Danek USA, Inc.201627—
+5K161379ELSA SpacersGlobus Medical, Inc.2016155—
+5K153665Prow Fusion-LNlt Spine, Ltd.20160—
+5K161627PASS LP Spinal SystemMedicrea International SA20167—
+5K152099Genesys Spine Apache® Anchored Cervical Interbody Fusion SystemGenesys Spine201619—
+5K161404Genesys Spine Apache® Lateral Lumbar Interbody Fusion SystemGenesys Spine201610—
+5K153621Juliet® TiSpineart2016751
+5K153786Prow Fusion-VNlt Spine, Ltd.20166—
+5K160874Nanovis Intervertebral Body Fusion System and FortiCore®Nanovis, LLC20164—
+5K161363Arsenal Spinal Fixation SystemAlphatec Spine, Inc.201675—
+5K160989NuVasive® Reline® SystemNu Vasive, Incorporated201667—
+5K153436LATERAL Spine Truss System4Web, Inc.20165—
+5K160154ALTA Anterior Cervical Interbody SpacerAstura Medical201663—
+5K160324Cervical Interbody Fusion SystemEvolution Spine, LLC20162—
+5K160124LUMIS Cannulated Pedicle Screw Fixation System, U.L.I.S. Pedicle Screw Fixation SystemSpinevision S.A.20162—
+5K153782NuVasive® Lumbar Interbody ImplantsNu Vasive, Incorporated2016390—
+5K153627NuVasive® TLX Interbody SystemNu Vasive, Incorporated2016252—
+5K151665SUSTAIN Additional ImplantsGlobus Medical, Inc.2016119—
+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—
+5K153373CORNERSTONE PSR Cervical Fusion System, PERIMETER C Spinal System, PEEK PREVAIL Cervical…Medtronic Sofamor Danek2016110—
+5K152604KYPHON HV-R Fenestrated Screw Cement, CD HORIZON Fenestrated Screw SetMedtronic Sofamor Danek USA, Incorporated2016159—
+5K151310Amendia Interbody Fusion DevicesAmendia, Inc.2016169—
+5K152968Arsenal Spinal Fixation SystemAlphatec Spine, Inc.201583—
+5K152532AERO -C Cervical Cage SystemStryker Spine2015145—
+5K152355Twin Peaks Lumbar Interbody Fusion SystemSpineway20151—
+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—
+5K143450Ackermann Intervertebral Body Fusion DeviceAckermann Instrumente GmbH20150—
+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—
+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—
+5K143595NuVasive (R) CCX-L Interbody SystemNu Vasive, Incorporated2015253—
+5K143684NuVasive Reline SystemNu Vasive, Incorporated201577—
+5K141798Sypher Spacer SystemBiogennix, LLC20151—
+5K150178CD Horizon Spinal SystemMedtronic Sofamor Danek USA, Inc.201525—
+5K142940Endoskeleton TCS SystemTitan Spine, LLC20151112
+5K141599Divergence Anterior Cervical Fusion SystemMedtronic Sofamor Danek USA, Inc.201516—
+5K142360Everest Spinal SystemK2m, Inc.201522—