510(k) Report

Devices descending from K021791

2,047 later devices reach Verte-Stack Spinal System through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+4K180056Genesys Spine AIS-C Cervical Anchored Interbody SystemGenesys Spine201818—
+4K173249CD HORIZON™ Spinal SystemMedtronic Sofamor Danek USA, Inc.20181—
+4K172320Neurostructures Cavetto® Cervical Cage SystemNeurostructures, Inc.20183—
+4K172105The Plateau-LO Spacer SystemLife Spine, Inc.20181—
+4K172185Tyber Medical PT Interbody Spacer SystemTyber Medical, LLC20177—
+4K172330Blustone Synergy Silica SystemBlustone Synergy20170—
+4K173182ProLift® Expandable SystemLife Spine, Inc.201737—
+4K170389TAURUS PEEK Cage SystemMedyssey USA, Inc.20170—
+4K172009Cascadia Interbody SystemK2m, Inc.2017433
+4K173148ACIFColigne AG20171—
+4K163595IMPIX 3D Print CagesMedicrea International SA2017282
+4K172328SOVEREIGN™ Spinal SystemMedtronic Sofamor Danek USA, Inc.201730—
+4K172341NuVasive® Modulus TLIF Interbody SystemNu Vasive, Incorporated2017163—
+4K163366Shanghai Sanyou CARMEN Cervical Fusion SystemShanghai Sanyou Medical Co, Ltd.20170—
+4K170119Calix Lumbar Spinal Implant SystemX-Spine Systems, Inc.201711
+4K171633NuVasive TLX Interbody SystemNu Vasive, Incorporated2017251—
+4K171107CAPSTONE CONTROL Spinal System, CAPSTONE CONTROL PTC Spinal SystemMedtronic Sofamor Danek USA, Inc.20178—
+4K171893Blustone Synergy Lumbar Interbody Fusion System (Basalt, Magma, Obsidian), Blustone…Bluestone Synergy20172—
+4K171321K2M Navigation InstrumentsK2m201711
+4K171140Matrixx SystemNexxt Spine, LLC2017145—
+4K171656Genesys Spine Apache Interbody Fusion SystemGenesys Spine20170—
+4K170844Gemini-C Hybrid Cervical Interbody SystemOsseus Fusion Systems, LLC20170—
+4K170297Tranquil Interbody SystemNexus Spine, LLC201715—
+4K163494Summit Spine Channel Cervical Interbody Fusion SystemSummit Spine20171—
+4K171468FUSE Spinal SystemMedtronic Sofamor Danek20170—
+4K170679CD HORIZON® Spinal System, Medtronic Reusable Instruments for Use with the IPC®…Medtronic Sofamor Danek201786—
+4K163581Navigated ELEVATE Inserter, Navigated Disc Prep InstrumentsMedtronic Sofamor Danek USA, Inc.2017103—
+4K162206Zavation IBFZavation, LLC201724—
+4K170347CD HORIZON™ Fenestrated Screw SetMedtronic Sofamor Danek USA201791—
+4K170243LOSPA IS TLIF & DLIF CagesCorentec Co., Ltd.20170—
+4K163230NuVasive Modulus XLIF Interbody SystemNu Vasive, Incorporated2017276—
+4K163301CD HORIZON® Spinal SystemMedtronic Sofamor Danek USA, Inc.20162—
+4K162680SOVEREIGN® Spinal SystemMedtronic Sofamor Danek USA, Inc.201631—
+4K160222OIC Cervical PEEK SpacerThe Orthopaedic Implant Company20160—
+4K162066Reliance Spinal Screw SystemReliance Medical Systems, LLC20163—
+4K160663Lumbar Interbody Fusion System (ALIF, PLIF, LLIF, TPLIF)Evolution Spine, LLC20160—
+4K162379CD HORIZON® Spinal SystemMedtronic Sofamor Danek USA, Inc.201645—
+4K161438Genesys Spine Apache® Anterior Lumbar Interbody Fusion SystemGenesys Spine201611—
+4K161842Overwatch Spine SystemAmendia, Inc.201661
+4K162494CD HORIZON® Spinal SystemMedtronic Sofamor Danek USA, Inc.201627—
+4K161379ELSA SpacersGlobus Medical, Inc.2016155—
+4K153665Prow Fusion-LNlt Spine, Ltd.20160—
+4K161627PASS LP Spinal SystemMedicrea International SA20167—
+4K152099Genesys Spine Apache® Anchored Cervical Interbody Fusion SystemGenesys Spine201619—
+4K161404Genesys Spine Apache® Lateral Lumbar Interbody Fusion SystemGenesys Spine201610—
+4K153621Juliet® TiSpineart2016751
+4K161223TransContinental® M Spacers and InterContinental® Plate-SpacersGlobus Medical, Inc.2016117—
+4K153786Prow Fusion-VNlt Spine, Ltd.20166—
+4K160874Nanovis Intervertebral Body Fusion System and FortiCore®Nanovis, LLC20164—
+4K161363Arsenal Spinal Fixation SystemAlphatec Spine, Inc.201675—
+4K160989NuVasive® Reline® SystemNu Vasive, Incorporated201667—
+4K153436LATERAL Spine Truss System4Web, Inc.20165—
+4K160154ALTA Anterior Cervical Interbody SpacerAstura Medical201663—
+4K160324Cervical Interbody Fusion SystemEvolution Spine, LLC20162—
+4K160124LUMIS Cannulated Pedicle Screw Fixation System, U.L.I.S. Pedicle Screw Fixation SystemSpinevision S.A.20162—
+4K153782NuVasive® Lumbar Interbody ImplantsNu Vasive, Incorporated2016390—
+4K153627NuVasive® TLX Interbody SystemNu Vasive, Incorporated2016252—
+4K151665SUSTAIN Additional ImplantsGlobus Medical, Inc.2016119—
+4K153438PERIMETER C (Titanium) Spinal SystemMedtronic Sofamor Danek USA, Inc.20160—
+4K153442CD HORIZON Spinal System, Medtronic Navigated Manual Reusable Instruments for Use with…Medtronic Sofamor Danek USA, Inc.201684—
+4K152781Adena-Zina SystemShanghai Sanyou Medical Co, Ltd.20165—
+4K153203Navigation InstrumentsGlobus Medical, Inc.2016112—
+4K153373CORNERSTONE PSR Cervical Fusion System, PERIMETER C Spinal System, PEEK PREVAIL Cervical…Medtronic Sofamor Danek2016110—
+4K152604KYPHON HV-R Fenestrated Screw Cement, CD HORIZON Fenestrated Screw SetMedtronic Sofamor Danek USA, Incorporated2016159—
+4K151310Amendia Interbody Fusion DevicesAmendia, Inc.2016169—
+4K152968Arsenal Spinal Fixation SystemAlphatec Spine, Inc.201583—
+4K152532AERO -C Cervical Cage SystemStryker Spine2015145—
+4K152355Twin Peaks Lumbar Interbody Fusion SystemSpineway20151—
+4K151770Libra Pedicle Screw SystemSpinal Balance, Inc.20151—
+4K152259InFill Interbody Fusion DevicePinnacle Spine Group, LLC20152—
+4K152277PIVOX (tm) Oblique Lateral Spinal SystemMedtronic Sofamor Danek USA, Inc.2015190—
+4K151819Integrity Spine Lumbar Interbody Fusion SystemIntegrity Spine Lumbar Interbody Fusion System20154—
+4K152248CD HORIZON Spinal SystemMedtronic Sofamor Danek USA, Inc.20150—
+4K152457CD HORIZON Spinal SystemMedtronic Sofamor Danek USA, Inc.2015145—
+4K152131Reliance Spinal Screw SystemReliance Medical Systems, LLC20154—
+4K143450Ackermann Intervertebral Body Fusion DeviceAckermann Instrumente GmbH20150—
+4K151472NuVasive CoRoent Lumbar SystemNu Vasive, Incorporated2015479—
+4K151322Amendia Interbody Fusion DevicesAmendia, Inc.20152261
+4K151538NuVasive PEEK Corpectomy Railed SystemNu Vasive, Incorporated201513—
+4K151167NuVasive PEEK Corpectomy SystemNu Vasive, Incorporated201513—
+4K150812Genesys Spine Apache Cervical Interbody Fusion SystemGenesys Spine201512—
+4K150673SYNFIX Evolution Secured Spacer SystemSynthes (USA) Products, LLC2015137—
+4K151756Sterispine LC CageSafe Orthopaedics20150—
+4K151196Nautilus Spinal SystemLife Spine, Inc.201512—
+4K150321EVOS Lumbar Interbody SystemCutting Edge Spine, LLC201592—
+4K150994NuVasive CoRoent Thoracolumbar ImplantsNu Vasive, Incorporated2015402—
+4K150135DIVERGENCE-L Anterior/Oblique Lumbar Fusion SystemMedtronic Sofamor Danek USA, Inc.2015228—
+4K143572Intersomatic Cervical Device - DICOM PEEK, Intersomatic Intervertebral Space Maintenance…Osteomed Implantes, Ltda20150—
+4K151215Mercury Spinal SystemSpinal Elements, Inc.20158—
+4K143595NuVasive (R) CCX-L Interbody SystemNu Vasive, Incorporated2015253—
+4K143684NuVasive Reline SystemNu Vasive, Incorporated201577—
+4K141798Sypher Spacer SystemBiogennix, LLC20151—
+4K150178CD Horizon Spinal SystemMedtronic Sofamor Danek USA, Inc.201525—
+4K142940Endoskeleton TCS SystemTitan Spine, LLC20151112
+4K141599Divergence Anterior Cervical Fusion SystemMedtronic Sofamor Danek USA, Inc.201516—
+4K142360Everest Spinal SystemK2m, Inc.201522—
+4K141253New Era Orthopaedics Polyscrew Pedicle Screw SystemNew Era Orthopaedics, LLC201511
+4K142328nvcNvision Biomedical Technologies, LLC20144—
+4K142737MAS PLIF Fixation systemNu Vasive, Incorporated20141—
+4K143141CD HORIZON Spinal SystemMedtronic Sofamor Danek USA, Inc.201416—