510(k) Report

Devices descending from K122630

405 later devices reach IN:C2 Spinal Fixation System through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K152515TOMCAT Cervical Spinal SystemChoicespine, LP2015108—
+1K142218Coalition AGX Plate and Coalition AGX SpacerGlobus Medical, Inc.2015155—
+1K141537IN:C2 Spinal Fixation SystmeSpine Smith Holdings, LLC20140—
+1K141005Z-Link CervicalZavation, LLC20144—
+1K133494Chesapeake Spinal SystemK2m, Inc.2014330—
+2K250764SpineLinc Anterior Cervical Implant SystemLincotek Medical20250—
+2K250769Dakota LP SystemPrecision Spine, Inc.20250—
+2K220334MONET Anterior Cervical Plate SystemCtl Medical Corporation20220—
+2K221049Zavation VariSync Plate System and VariSync Spacer SystemZavation Medical Products, LLC20226—
+2K191243HEDRON Cervical SpacersGlobus Medical, Inc.201936—
+2K190885Elevation Spine Saber-C SystemElevation Spine201925—
+2K173077Cavetto-SA Cervical Cage SystemNeurostructures, Inc.201821—
+2K173115COALITION® and COALITION® TPS, COALITION MIS® and COALITION MIS® TPS, COALITION AGX® and…Globus Medical, Inc.201783—
+2K172019Brisbane ALIF Device, Gladstone ALIF DeviceSignature Orthopaedics Pty, Ltd.20170—
+2K170953Tomcat Cervical Spinal SystemChoicespine, LP2017103—
+2K163474CAVUX CervicalCage-L SA SystemProvidence Medical Technology, Inc.20170—
+2K152022SUSTAIN® R Spacers, PATRIOT® Spacers, CALIBER® Spacers, RISE® Spacers, COALITION®…Globus Medical, Inc.2017149—
+2K160125Cascadia Interbody SystemK2m2016315—
+2K152793Unison-C Anterior Cervical Fixation SystemPioneer Surgical Technology, Inc., Dba Rti Surgical, Inc.201629—
+2K152972Amendia Stand-Alone Cervical SystemAmendia, Inc.201632
+2K142487Chesapeake Stabilization SystemK2m, Inc.201571
+2K142940Endoskeleton TCS SystemTitan Spine, LLC20151112
+3K252982CONDUIT™ ZERO-P™ VA Secured Spacer SystemAvalign Technologies, Inc.20260—
+3K260660SABER-C SystemElevation Spine20261—
+3K253260ORIO-3D Cage SystemSpineCraft20260—
+3K253876HEDRON™ Cervical Spacers (HEDRON C-MIS™ Spacer)Globus Medical, Inc.20251—
+3K250335IVA & AEON Cervical and Lumbar Cage SystemK&J Consulting20250—
+3K250540SABER-C SystemElevation Spine20252—
+3K241396uCerv Flux™-C 3D Porous Titanium Cervical InterbodyUlrich Medical USA, Inc.20240—
+3K233509Zavation IBF System, Zavation Varisync Plate System and Varisync Spacer System…Zavation Medical Products, LLC20241—
+3K230478Acro Composites Interbody SystemAcro Composites, LLC20230—
+3K223869ChoiceSpine Blackhawk Ti Cervical Spacer SystemChoice Spine, LLC20232—
+3K231147Hammerdesis™ Interphalangeal Fusion SystemIntelivation20230—
+3K231766Skyway Anterior Cervical Plate SystemKyocera Medical Technologies Inc. (KMTI)20233—
+3K232150ZSFab Cervical Interbody SystemZsfab, Inc.20234—
+3K230936Anatomic PEEK™ Cervical Fusion System with NanotechnologyNanovis, LLC20230—
+3K223837SPIRA®-C Integrated Fixation SystemCamber Spine Technologies20230—
+3K221490Tritanium C Anterior Cervical Cage, Tritanium PL Cage, Tritanium TL Curved Posterior…Stryker Spine20231—
+3K223105Tesera-K SC SystemKyocera Medical Technologies, Inc.20225—
+3K223190Hive™ Standalone Cervical SystemNanoHive Medical, LLC20225—
+3K222270HEDRON Cervical Spacers, HEDRON Lumbar Spacers, SABLE Expandable Spacer, ExcelsiusGPS…Globus Medical, Inc.202223—
+3K220696uCerv Flux-C 3D Porous Titanium Cervical InterbodyUlrich Medical USA20221—
+3K211417F3D-C2 Cervical Stand-Alone SystemCorelink, LLC20223—
+3K212853Cervical Stand-Alone SystemEminent Spine, LLC202118—
+3K211903Shoreline Threaded TruProfile® PlateSeaSpine Orthopedics Corporation20217—
+3K210382Blustone Synergy Diamond SA Cervical SystemBlustone Synergy, LLC20210—
+3K210044Crystal Spinal System & Vertu Spinal System, Lucent Spinal System, Zeus Spinal System…Spinal Elements, Inc.20211—
+3K203311ChoiceSpine Blackhawk Ti Cervical Spacer SystemChoice Spine, LLC20213—
+3K203129NexGen Standalone Anterior Cervical Discectomy and Fusion (ACDF) SystemPrecision Spine, Inc.20210—
+3K202488ZSFab Cervical Interbody SystemZsfab, Inc.20216—
+3K202812IdentiTi Cervical Standalone Interbody SystemAlphatec Spine, Inc.202067—
+3K200549Lucero Medical Cervical Cage SystemLucero Medical, LLC20200—
+3K203076Mecta-C Stand Alone ExtensionMedacta International S.A.20200—
+3K202065DOLOMITE Anterior Cervical Stabilization SystemAstura Medical, LLC20203—
+3K200115Cavetto-SA Cervical Cage SystemNeurostructures, Inc.202019—
+3K201073Seaspine WaveForm C Interbody SystemSeaSpine Orthopedics Corporation202017—
+3K200087F3D Cervical Stand-Alone Interbody Fusion SystemCorelink, LLC202025—
+3K193359SureMAX Family of Cervical SpacersAdditive Implants, Inc.202014—
+3K191477AEON-C Stand Alone SystemHuvexel Co., Ltd.201910—
+3K192208CORNICE Cervical Spacer SystemLegend Spine Technologies20190—
+3K191537eCarbon IBDsBack 2 Basics Direct, LLC20193—
+3K191621ChoiceSpine Octane A/T/P Spinal Implant System, ChoiceSpine Cervical Interbody Spacer…Choice Spine, LLC20194—
+3K191565Endoskeleton TCS Interbody Fusion DeviceTitan Spine, Inc.201901
+3K182477Cervical SpacerAdditive Implants, LLC201915—
+3K182210TiWAVE-L Porous Titanium Lumbar CageKalitec Medical, LLC20193—
+3K180909REVEL SpacersGlobus Medical, Inc.201837—
+3K181357PATRIOT® Lumbar Spacers, SUSTAIN® SpacersGlobus Medical, Inc.201897—
+3K180401TiWAVE-C™ Porous Titanium Cervical CageKalitec Direct, LLC20185—
+3K180519HARRIER-SA™ Lumbar Interbody SystemChoicespine, LP20180—
+3K171312FortiCore®Nanovis, LLC20183—
+3K171489Acapella Cervical Spacer SystemChoicespine, LP201739—
+3K171567IRIX-A Lumbar Integrated Fusion SystemX-Spine Systems, Inc.201701
+3K171140Matrixx SystemNexxt Spine, LLC2017145—
+3K170318NeoFuse Ti3D PLIF/TLIF/Cervical InterbodyHt Medical, LLC201749—
+3K170399Endoskeleton TO Interbody Fusion Device (IBD)Titan Spine, LLC2017105—
+3K170830Unison-C Anterior Cervical Fixation SystemPioneer Surgical Technology, Inc., Dba Rti Surgical, Inc.20175—
+3K170055CAPRI Corpectomy Cage SystemK2m201711—
+3K163364MOJAVE Expandable Interbody SystemK2m201725—
+3K161993Leva® Anterior Interbody SystemSpine Wave, Inc.20160—
+3K162264Cascadia Interbody SystemK2m, Inc.2016169—
+3K151481Sahara Stabilization SystemK2m, Inc.20155—
+3K153122Endoskeleton (r) TCS SystemTitan Spine, LLC20151061
+3K151596Endoskeleton TCS Interbody Fusion DeviceTitan Spine, LLC20151101
+4K263049SABER-C SystemElevation Spine20260—
+4K261882Pisces-SC Standalone Cervical Interbody SystemOsseus Fusions Systems, LLC20260—
+4K261049Scala® TLSpineart SA20260—
+4K262061Tritanium® C Anterior Cervical Cage; Tritanium® PL Cage; Tritanium® TL Curved Posterior…Stryker Spine20260—
+4K253420Admiral ACP System; Explorer TO System; Laminoplasty System; Manta Ray TDF Spacer…SeaSpine Orthopedics Corporation20260—
+4K253401SCRIPT™ Implant SystemGlobus Medical, Inc.20260—
+4K254105Hive™ Standalone Cervical System and Hive™ C Interbody SystemNanoHive Medical, LLC20260—
+4K250599ExcelsiusGPS™ InstrumentsGlobus Medical, Inc.20250—
+4K252737DeGen Medical Latitude-C AM Cervical Interbody Fusion SystemDegen Medical20250—
+4K251735Stabilis SA Cervical Stand-Alone System (Various PNs)Acuity Surgical Devices, LLC20251—
+4K242928Tesera-k SC SystemKyocera Medical Technologies, Inc.20250—
+4K243635aprevo® anterior lumbar interbody fusion device with interfixationCarlsmed, Inc.20245—
+4K242517ProAM ACDF SystemPro Surgical, Inc.20240—
+4K242260aprevo® Cervical ACDF; aprevo® Cervical ACDF-X; aprevo® Cervical ACDF-X NO CAMCarlsmed, Inc.20243—
+4K241468Vertiwedge® Intraosseous SystemFoundation Surgical Group, Inc.20241—
+4K242734ZSFab Cervical Interbody System; ZSFab Lumbar Interbody SystemZsfab20243—
+4K243015Skyway Anterior Cervical Plate SystemKyocera Medical Technologies, Inc.20242—