510(k) Report

Devices descending from K081194

163 later devices reach Interplate Peek Cervical Interbody Fusion Device (Ifd) through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K121151Pro-Link Cervical Spacer SystemLife Spine, Inc.2012116—
+1K092540C-PS Peek Optima Cervical Interbody Spacer, L-PS Peek Optima Lumbar Interbody SpacerRsb Spine, LLC201045—
+2K231704Pro-Link® & Pro-Link® Ti Barbs Cervical Spacer SystemLife Spine, Inc.20230—
+2K180642Pro-Link® Ti Stand-Alone Cervical Spacer SystemLife Spine, Inc.20182—
+2K160222OIC Cervical PEEK SpacerThe Orthopaedic Implant Company20160—
+2K160066Pro-Link® Stand-Alone Cervical Spacer SystemLife Spine, Inc.20163—
+2K152793Unison-C Anterior Cervical Fixation SystemPioneer Surgical Technology, Inc., Dba Rti Surgical, Inc.201629—
+2K132029Vault-C Intervertebral Body Fusion DeviceSpinal USA2013108—
+2K120656Everest Spinal SystemK2m, Inc.201243—
+3K240715Idys® C ZP 3DTiClariance20240—
+3K211417F3D-C2 Cervical Stand-Alone SystemCorelink, LLC20223—
+3K212853Cervical Stand-Alone SystemEminent Spine, LLC202118—
+3K212562Idys-C ZP 3DTiClariance, SA20211—
+3K203129NexGen Standalone Anterior Cervical Discectomy and Fusion (ACDF) SystemPrecision Spine, Inc.20210—
+3K200087F3D Cervical Stand-Alone Interbody Fusion SystemCorelink, LLC202025—
+3K190870Cervical Spinal Truss System-Stand Alone (CSTS-SA)4Web, Inc.201910—
+3K191565Endoskeleton TCS Interbody Fusion DeviceTitan Spine, Inc.201901
+3K190546NEXXT MATRIXX Stand Alone Cervical SystemNexxt Spine, LLC201993—
+3K170830Unison-C Anterior Cervical Fixation SystemPioneer Surgical Technology, Inc., Dba Rti Surgical, Inc.20175—
+3K140529Everest Spinal SystemK2m, LLC201431—
+3K133944Range, Spinal System, Everest Spinal SystemK2m, Inc.201433—
+3K132757Everest Spinal SystemK2m, Inc.201341—
+3K132361Everest Spinal SystemK2m, Inc.201334—
+4K260036NeckTune™ 3D SA Cervical CageMedyssey Co, Ltd.20260—
+4K253545Vulcan Spinal SystemK2m, Inc.20260—
+4K251735Stabilis SA Cervical Stand-Alone System (Various PNs)Acuity Surgical Devices, LLC20251—
+4K242361OZARK Cervical Plate System; PYRENEES® Cervical Plate System; EVEREST® Spinal System…Stryker Spine20241—
+4K240838Spectrum Spine Cervical Cage SystemSpectrum Spine, Inc.20244—
+4K232348RIGEL™ 3DR Standalone Anterior Cervical Interbody Fusion SystemMiRus, LLC20231—
+4K231739Cervical Spine Truss System (CSTS)4Web Medical, Inc.20232—
+4K230608SPICCA Stand-Alone Cervical Fusion CagesSouthern Medical (Pty), Ltd.20230—
+4K230329F3D Interbody SystemCorelink, LLC20230—
+4K223362Cervical Spine Truss System - Stand Alone (CSTS-SA) Interbody Fusion Device4Web Medical, Inc.20233—
+4K223105Tesera-K SC SystemKyocera Medical Technologies, Inc.20225—
+4K223190Hive™ Standalone Cervical SystemNanoHive Medical, LLC20225—
+4K222903Tailored-H Cervical Stand Alone SystemBespoke Technologies, LLC20220—
+4K212527Cervical Spine Truss System Plating Solution (CSTS-PS)4Web Medical, Inc.20220—
+4K193000Hexanium® ACIFSpinevision, S.A.S.202014—
+4K201453Fortilink Cages with TiPlus TechnologyParadigm Spine GmbH20204—
+4K193153SPIRA-C Integrated Fixation SystemCamber Spine Technologies20202—
+4K200543NEXXT MATRIXX Stand Alone Cervical-Turn Lock (-TL) SystemNexxt Spine, LLC202072—
+4K173508Everest Spinal SystemK2m20189—
+4K151727Everest Spinal SystemK2m, Inc.201511—
+4K142360Everest Spinal SystemK2m, Inc.201522—
+4K143334Range/Denali/Mesa Spinal SystemK2m, Inc.201516—
+4K141873Range/Mesa/Denali Spinal SystemK2m, Inc.201430—
+4K140765Range/Mesa/Denali Spinal SystemK2m, Inc.201415—
+4K141147Range Spinal SystemK2m, Inc.20141—
+5K261882Pisces-SC Standalone Cervical Interbody SystemOsseus Fusions Systems, LLC20260—
+5K254130C.A. Medical Interbody Fusion SystemC.A. Medical, LLC20260—
+5K253894BMD Titanium Spinal Fusion SystemGlobal Biomedica s.r.o.20260—
+5K252240Spectrum Spine Cervical Cage System; Spectrum Spine Lumbar Cage SystemSpectrum Spine20260—
+5K254105Hive™ Standalone Cervical System and Hive™ C Interbody SystemNanoHive Medical, LLC20260—
+5K253200Cervical Spine Truss System - Stand Alone (CSTS-SA)4Web Medical, Inc.20250—
+5K253377Expandable Titanium PLIF/TLIF SystemSpectrum Spine, Inc.20250—
+5K251719Momentum® Posterior Spinal Fixation SystemUlrich Medical USA, Inc.20250—
+5K251117Cervical Spine Truss System (CSTS)4Web Medical20250—
+5K242928Tesera-k SC SystemKyocera Medical Technologies, Inc.20250—
+5K243074Spectrum Spine Lumbar Cage SystemSpectrum Spine, Inc.20252—
+5K242260aprevo® Cervical ACDF; aprevo® Cervical ACDF-X; aprevo® Cervical ACDF-X NO CAMCarlsmed, Inc.20243—
+5K233966Anterior Spine Truss System-Stand Alone (ASTS-SA)4Web Medical, Inc.20241—
+5K231766Skyway Anterior Cervical Plate SystemKyocera Medical Technologies Inc. (KMTI)20233—
+5K223837SPIRA®-C Integrated Fixation SystemCamber Spine Technologies20230—
+5K221578Hexanium ACIFSpinevision, S.A.S.20224—
+5K221905INERTIA CONNEXX Modular Pedicle Screw SystemNexxt Spine, LLC20221—
+5K210963ENNOVATE Spinal SystemAesculap Implant Systems, LLC20210—
+5K211111SureMAX-SA Cervical Standalone SystemAdditive Implants, Inc.20218—
+5K202812IdentiTi Cervical Standalone Interbody SystemAlphatec Spine, Inc.202067—
+5K181119Range (Denali and Mesa) Spinal SystemsK2m, Inc.20185—
+5K180376K2M Patient Specific RodsK2m, Inc.20182—
+5K171832Range/Denali/Mesa Spinal SystemK2m, Inc.201713—
+5K161028K2M Growing Spine SystemK2m, Inc.20163—
+5K161369EVEREST Spinal SystemK2m, Incorporated20169—
+5K160208NILE Alternative Fixation Spinal SystemK2m, Inc.20165—
+5K153031RANGE/DENALI/MESA Spinal SystemK2m, Incorporated20152—
+5K151216Everest Spinal SystemK2m, Inc.201511—
+5K150325Range/Denali/Mesa Spinal SystemK2m, Inc.201512—
+5K133402K2M Modular HooksK2m, Inc.20140—
+6K250827aprevo® anterior lumbar interbody fusion device; aprevo® lateral lumbar interbody fusion…Carlsmed, Inc.20252—
+6K243934Stable-L Lumbar Interbody SystemNexus Spine, LLC20250—
+6K243015Skyway Anterior Cervical Plate SystemKyocera Medical Technologies, Inc.20242—
+6K232341CarboClear® Pedicle Screw SystemCarboFix Orthopedics, Ltd.20234—
+6K231799INERTIA® CONNEXX™ Modular Pedicle Screw SystemNexxt Spine, LLC20230—
+6K222684XIA® 4.5 Spinal System, XIA® 4.5 Cortical Trajectory, XIA® 3 Spinal System, Serrato®…Stryker Spine20234—
+6K220782IdentiTi™ Porous Ti Interbody System, IdentiTi™ NanoTec™ Interbody System, Transcend™…Alphatec Spine, Inc.202236—
+6K212358Romero Cervical CageSpineup, Inc.20226—
+6K203742IdentiTi ALIF Standalone Interbody SystemAlphatec Spine, Inc.202159—
+6K181603EVEREST Spinal System, RANGE (MESA and DENALI) Spinal System, CASPIAN OCT (MESA Mini and…K2m, Inc.20185—
+6K181068CREO® Stabilization System, REVERE® Stabilization SystemGlobus Medical, Inc.20182—
+6K181188EVEREST Spinal SystemK2m, Inc.20186—
+6K171321K2M Navigation InstrumentsK2m201711
+6K153525Seneka II Polyscrew Pedicle Fixation SystemSenecka Spine20160—
+7K260385aprevo® anterior and lateral lumbar interbody system; aprevo® posterior and…Carlsmed, Inc.20260—
+7K253739SCRIPT™ Rods, CREO™ Stabilization System, REVERE® Stabilization System, REVERE® 4.5…Globus Medical, Inc.20260—
+7K252894aprevo® cervical interbody systemCarlsmed, Inc.20261—
+7K252781MSFX Mikron Peek CagesMikron Makina Sanayi VE Tic. Ltd. Sti.20251—
+7K251575IdentiTi™ II ALIF Standalone Interbody System; Transcend™ ALIF Standalone Interbody SystemAlphatec Spine20250—
+7K250486Skyway Anterior Cervical Plate SystemKyocera Medical Technologies Inc. (KMTI)20251—
+7K233793CarboClear® X Pedicle Screw SystemCarboFix Orthopedics, Ltd.20241—
+7K240893ARTFX MEDICAL Cervical PEEK CagesArtfx Medical20244—