510(k) Report

Devices descending from K040731

895 later devices reach Stryker Spine Vertebral Spacer through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+5K162133VerteFIT Corpectomy Cage SystemLdr Spine USA, Inc.20170—
+5K170243LOSPA IS TLIF & DLIF CagesCorentec Co., Ltd.20170—
+5K162693VertebraLINK Fusion PlatformFacetlink Dba Linkspine20170—
+5K1624024CIS® Marlin ACIF Cage SystemSolco Biomedical Co., Ltd.20171—
+5K160976Altus Spine Interbody Fusion SystemAltus Partners, LLC20178—
+5K161127The Small PLATEAU (PLATEAU-C) Spacer SystemLife Spine, Inc.20166—
+5K161809ShurFit CpTi-HA ACIF Interbody Fusion SystemPrecision Spine, Inc.20165—
+5K160924Amendia Interbody Fusion DevicesAmendia, Inc.2016166—
+5K153665Prow Fusion-LNlt Spine, Ltd.20160—
+5K160699VIRTU Lumbar Spacer SystemMet 1 Technologies, LLC20162—
+5K161223TransContinental® M Spacers and InterContinental® Plate-SpacersGlobus Medical, Inc.2016117—
+5K160154ALTA Anterior Cervical Interbody SpacerAstura Medical201663—
+5K152200SurgTech Interbody SystemSurgtech, Inc.20160—
+5K153356Spine Innovation Interbody SystemSpine Innovation, LLC20161—
+5K150847Foundation Interbody DevicesCorelink, LLC201529—
+5K142744Mecta-C TiPEEKMedacta International201512—
+5K140348Interbody CageEisertech, LLC2015235—
+5K142940Endoskeleton TCS SystemTitan Spine, LLC20151112
+5K141333Arena-C Tifuse Cervical Intervertebral Body Fusion DeviceSpinefrontier, Inc.20140—
+5K142150Ais Modulift VBR SystemAesculap Implant System, Inc.201447—
+5K141953Endoskeleton; TA Ibd and VBR, to and TT, Tas, TC, TLTitan Spine, LLC20142652
+5K142589Endoskeleton TA IBD and VBR, Endoskeleton TO and TT, Endoskeleton TAS, Endoskeleton TAS…Titan Spine, LLC2014106—
+5K140563Lateral VBR SystemNu Vasive, Incorporated20140—
+5K133802Ais Modulift VBR SystemAesculap Implant System, Inc.201448—
+5K132738Cogent Med-LifCogent Spine, LLC201413—
+5K132582Exactech Acapella One Cervical Spacer SystemExactech, Inc.2014471
+5K133967Interbody Cage SystemAurora Spine2014227—
+5K133207Staxx (R) SystemSpine Wave, Inc.20131—
+5K131178Idys Lif CagesClariance201311—
+5K130434Octane Straight, Octane Straight - Lordotic, Octane Straight I/R, Octane Straight I/R -…Exactech, Inc.201311—
+5K122872Intervertebral Body Fusion DeviceDio Medical Co., Ltd.201316—
+5K122518Synster (Cervical,Alif, Plif, Ptlif and Tlif) Cage Hera Cervical Cage Rhea Plif Cage…Bm Korea Co., Ltd.20133—
+5K121649Construx Mini Peek TI Spacer SystemOrthofix2012289—
+5K1217414-Web Cervical STS (Spinal Truss System)4-Web, Inc.201235—
+5K111122Aesculap Sibd XP Spinal SystemAesculap Implant Systems, Inc.2011460—
+6K261408SABER-XA SystemElevation Spine20260—
+6K261430TruLift Expandable SystemLife Spine, Inc.20260—
+6K2530413d Cage CervicalFims Co., Ltd.20260—
+6K254130C.A. Medical Interbody Fusion SystemC.A. Medical, LLC20260—
+6K252982CONDUIT™ ZERO-P™ VA Secured Spacer SystemAvalign Technologies, Inc.20260—
+6K253894BMD Titanium Spinal Fusion SystemGlobal Biomedica s.r.o.20260—
+6K261067BEE PLIF CageNGMedical GmbH20260—
+6K253401SCRIPT™ Implant SystemGlobus Medical, Inc.20260—
+6K252240Spectrum Spine Cervical Cage System; Spectrum Spine Lumbar Cage SystemSpectrum Spine20260—
+6K252432Flex-Z™ Cervical CageSpinepoint, LLC20260—
+6K254105Hive™ Standalone Cervical System and Hive™ C Interbody SystemNanoHive Medical, LLC20260—
+6K260038E3D™-C Interbody SystemEvolution Spine20261—
+6K253266Titanium Interbody SystemSpine Innovation, LLC20260—
+6K253876HEDRON™ Cervical Spacers (HEDRON C-MIS™ Spacer)Globus Medical, Inc.20251—
+6K250560BEE HANGMedical GmbH20250—
+6K250599ExcelsiusGPS™ InstrumentsGlobus Medical, Inc.20250—
+6K253377Expandable Titanium PLIF/TLIF SystemSpectrum Spine, Inc.20250—
+6K250072CONDUIT™ SYNFIX™ Evolution Secured Spacer SystemAvalign Technologies, Inc.20251—
+6K251459OneLIF™ Interbody Fusion SystemNovapproach Spine, LLC20250—
+6K251335Tera Lumbar Interbody Fusion System (Various PNs)Acuity Surgical Devices, LLC20251—
+6K242928Tesera-k SC SystemKyocera Medical Technologies, Inc.20250—
+6K243074Spectrum Spine Lumbar Cage SystemSpectrum Spine, Inc.20252—
+6K250605EVOL® ha – Hyper C Cervical Interbody Fusion SystemCutting Edge Spine, LLC20250—
+6K243461Calibrate Interbody SystemsAlphatec Spine, Inc.20250—
+6K243670Idys® LIFClariance20240—
+6K242260aprevo® Cervical ACDF; aprevo® Cervical ACDF-X; aprevo® Cervical ACDF-X NO CAMCarlsmed, Inc.20243—
+6K242147Calibrate LTX Interbody System; Calibrate NanoTec LTX Interbody SystemAlphatec Spine, Inc.20241—
+6K242509HAnano InterFuse (R) Modular InterbodyNext Orthosurgical20240—
+6K234035COSINE™ SpacerGlobus Medical, Inc.20240—
+6K241413sagAlign Lumbar Cage System (Various PNs)Acuity Surgical Devices, LLC20240—
+6K234077SPIRA® Anterior Lumbar SpacersCamber Spine Technologies20240—
+6K240830Reef TO/TA System; Regatta Lateral System; Explorer TO System; WaveForm C Interbody…Orthofix Medical, Inc.20242—
+6K241466Shoreline ACS Interbody System; Shoreline RT Interbody System; Regatta Lateral System…SeaSpine Orthopedics Corporation20243—
+6K240749PILLAR SA Ti Spacer System (82-XXX)Orthofix, Inc.202402
+6K240699SCARLET® AC-TiSpineart SA20240—
+6K233509Zavation IBF System, Zavation Varisync Plate System and Varisync Spacer System…Zavation Medical Products, LLC20241—
+6K232792icotec Interbody Cage System (icotec Cervical Cage, icotec PLIF Lumbar Cage, icotec…Icotec AG20240—
+6K232432E3D™-A Interbody SystemEvolution Spine20248—
+6K233735ADIRA™ Lateral Plate SystemGlobus Medical, Inc.20240—
+6K233744Curiteva Porous PEEK Lumbar Interbody Fusion SystemCuriteva, Inc.20242—
+6K231743F3D Lateral Lumbar Interbody System, CL5 Lateral Lumbar Interbody System, and Oro…Corelink, LLC20233—
+6K230639Align Cervical Interbody Fusion SystemAcuity Surgical Devices, LLC20232—
+6K231899HAtetracell™-C Titanium Cervical IBF SystemInnovasis, Inc.20232—
+6K232173Ascend VBR System, Ascend NanoTec VBR SystemAlphatec Spine, Inc.20230—
+6K223869ChoiceSpine Blackhawk Ti Cervical Spacer SystemChoice Spine, LLC20232—
+6K231766Skyway Anterior Cervical Plate SystemKyocera Medical Technologies Inc. (KMTI)20233—
+6K230607SPICCA Cervical Fusion CagesSouthern Medical (Pty), Ltd.20230—
+6K230608SPICCA Stand-Alone Cervical Fusion CagesSouthern Medical (Pty), Ltd.20230—
+6K222874CarboClear Cervical Cage System, CarboClear Cervical VBR SystemCarbofix Orthpedics, Ltd.20230—
+6K231808QUASAR Standalone ACIF SystemGS Medical Co., Ltd.20230—
+6K231438Calibrate PSX Interbody System, Calibrate NanoTec PSX Interbody SystemAlphatec Spine, Inc.20237—
+6K231241NanoHive Medical Lumbar Interbody SystemNanoHive Medical, LLC20230—
+6K230731Zavation ALIF SystemZavation Medical Products, LLC20232—
+6K230851Kodiak Lumbar Spacer SystemMet One Technologies, LLC20230—
+6K220513NITRO Interbody Fusion Cage System FamilyCtl Medical Corporation20230—
+6K230583Tryptik TiSpineart SA20231—
+6K223043The Integrity Spine Core SystemIntegrity Spine20230—
+6K213030Curiteva Porous PEEK Cervical Interbody Fusion SystemCuriteva, Inc.20233—
+6K223190Hive™ Standalone Cervical SystemNanoHive Medical, LLC20225—
+6K221806TruLift Lateral Expandable Spacer System & Lateral Plate SystemLife Spine, Inc.20221—
+6K222455Calibrate LTX Interbody SystemAlphatec Spine, Inc.20228—
+6K222973IdentiTi and Transcend Interbody Systems: IndentiTi Cervical Porous Ti Interbody System…Alphatec Spine, Inc.202213—
+6K221719ABTross ALIF Expandable Cage SystemAegis Spine, Inc.20222—
+6K222270HEDRON Cervical Spacers, HEDRON Lumbar Spacers, SABLE Expandable Spacer, ExcelsiusGPS…Globus Medical, Inc.202223—
+6K222028IdentiTi™ Porous Ti Interbody System, IdentiTi™ NanoTec™ Interbody System, Transcend™…Alphatec Spine202228—