510(k) Report

Devices descending from K133967

227 later devices reach Interbody Cage System through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K230639Align Cervical Interbody Fusion SystemAcuity Surgical Devices, LLC20232—
+1K223043The Integrity Spine Core SystemIntegrity Spine20230—
+1K221535Align Lumbar Interbody Fusion SystemAcuity Surgical Devices, LLC20223—
+1K173082Arco™-SA Lumbar Cage SystemNeurostructures, Inc.20185—
+1K172064Ti-Diagon Oblique TLIFCamber Spine Technologies201727—
+1K171657ShurFit 2C Lumbar Interbody Fusion SystemPrecision Spine, Inc.20174—
+1K143578SUSTAIN R TPS Spacers, PATRIOT TPS Spacers, CALIBER TPS Spacer, COALITION TPS Spacers…Globus Medical, Inc.2016210—
+2K251735Stabilis SA Cervical Stand-Alone System (Various PNs)Acuity Surgical Devices, LLC20251—
+2K251335Tera Lumbar Interbody Fusion System (Various PNs)Acuity Surgical Devices, LLC20251—
+2K241413sagAlign Lumbar Cage System (Various PNs)Acuity Surgical Devices, LLC20240—
+2K221182Southern Transforaminal Lumbar Interbody Fusion (TLIF)Southern Medical (Pty), Ltd.20220—
+2K213420WaveForm L System, WaveForm TO System, WaveForm TA SystemSeaSpine Orthopedics Corporation202211—
+2K213118Dakota ALIF SystemPrecision Spine, Inc.20220—
+2K212904SeaSpine WaveForm C Interbody SystemSeaSpine Orthopedics Corporation202115—
+2K213359SeaSpine WaveForm, C Interbody SystemSeaSpine Orthopedics Corporation20217—
+2K212075ShurFit Lumbar Interbody SystemPrecision Spine, Inc.20211—
+2K212070KMTI S141 Lumbar Interbody Fusion SystemKyocera Medical Technologies, Inc.20210—
+2K210595SPIRA-T Oblique Posterior Lumbar Spacers, SPIRA-P Posterior Lumbar SpacersCamber Spine Technologies, LLC20213—
+2K202190Oculus-SA Lumbar Cage SystemNeurostructures20200—
+2K192248Cortina™ [MAX] Lumbar Cage SystemNeurostructures, Inc.20190—
+2K181357PATRIOT® Lumbar Spacers, SUSTAIN® SpacersGlobus Medical, Inc.201897—
+2K182195Arco™-SA Lumbar Cage SystemNeurostructures, Inc.20183—
+2K181261Curiteva Cervical Interbody Fusion SystemCuriteva, LLC20184—
+2K173722PATRIOT COLONIAL Spacer, SUSTAIN SpacerGlobus Medical, Inc.201894—
+2K171848FORTIFY and FORTIFY Integrated Corpectomy Spacers, XPand Corpectomy Spacers, NIKO…Globus Medical, Inc.201755—
+2K173115COALITION® and COALITION® TPS, COALITION MIS® and COALITION MIS® TPS, COALITION AGX® and…Globus Medical, Inc.201783—
+2K170157INDEPENDENCE® SpacersGlobus Medical, Inc.2017109—
+2K171075Calix-C Cervical Interbody SpacerX-Spine Systems, Inc.201715—
+2K161223TransContinental® M Spacers and InterContinental® Plate-SpacersGlobus Medical, Inc.2016117—
+3K261451ZSAlign Cervical Interbody SystemZSFab, Inc.20260—
+3K254130C.A. Medical Interbody Fusion SystemC.A. Medical, LLC20260—
+3K242303MOD-COrthomod, LLC20260—
+3K254105Hive™ Standalone Cervical System and Hive™ C Interbody SystemNanoHive Medical, LLC20260—
+3K253876HEDRON™ Cervical Spacers (HEDRON C-MIS™ Spacer)Globus Medical, Inc.20251—
+3K250560BEE HANGMedical GmbH20250—
+3K250335IVA & AEON Cervical and Lumbar Cage SystemK&J Consulting20250—
+3K240830Reef TO/TA System; Regatta Lateral System; Explorer TO System; WaveForm C Interbody…Orthofix Medical, Inc.20242—
+3K241466Shoreline ACS Interbody System; Shoreline RT Interbody System; Regatta Lateral System…SeaSpine Orthopedics Corporation20243—
+3K240566Reef L Interbody System; WaveForm L Interbody SystemSeaSpine Orthopedics Corporation20245—
+3K232256Alcantara Thoracolumbar Plate SystemCamber Spine Technologies, LLC20240—
+3K233414Shoreline ACS Interbody System; Shoreline RT Interbody SystemSeaSpine Orthopedics Corporation20238—
+3K232504Calibrate CCX Interbody SystemAlphatec Spine, Inc.202311
+3K221894Lumbar Expandable lnterbody Spacers -Additional Indications/ImplantsGlobus Medical, Inc.20232—
+3K230731Zavation ALIF SystemZavation Medical Products, LLC20232—
+3K221324ENZA-O Titanium Lateral Anterior Lumbar Interbody Fusion (ALIF)Camber Spine Technologies20230—
+3K223837SPIRA®-C Integrated Fixation SystemCamber Spine Technologies20230—
+3K213030Curiteva Porous PEEK Cervical Interbody Fusion SystemCuriteva, Inc.20233—
+3K220296Manta Ray TDF SpacerSeaSpine Orthopedics Corporation20231—
+3K223190Hive™ Standalone Cervical SystemNanoHive Medical, LLC20225—
+3K222732WaveForm A Interbody SystemSeaSpine Orthopedics Corporation20229—
+3K221172FOCUS Interbody SystemOc Medical Devices20220—
+3K211417F3D-C2 Cervical Stand-Alone SystemCorelink, LLC20223—
+3K211873PSX Interbody SystemAlphatec Spine, Inc.202111—
+3K210382Blustone Synergy Diamond SA Cervical SystemBlustone Synergy, LLC20210—
+3K203520Blustone Synergy Interbody Fusion SystemBlustone Synergy, LLC20210—
+3K203444BEE HA CageNGMedical GmbH20211—
+3K203278INDEPENDENCE Spacers, HEDRON IA, MAGNIFY-S Spacers, MONUMENT Spacers, InterContinental…Globus Medical, Inc.202135—
+3K202398Ti3Z Cervical Interbody SystemZavation Medical Products, LLC20219—
+3K203207Omnia Medical TiBrid-SAOmnia Medical, LLC202012
+3K203076Mecta-C Stand Alone ExtensionMedacta International S.A.20200—
+3K202065DOLOMITE Anterior Cervical Stabilization SystemAstura Medical, LLC20203—
+3K202305Zavation IBF SystemZavation Medical Products, LLC20209—
+3K201073Seaspine WaveForm C Interbody SystemSeaSpine Orthopedics Corporation202017—
+3K201585Monterey AL Interbody SystemStryker Corporation202044
+3K200087F3D Cervical Stand-Alone Interbody Fusion SystemCorelink, LLC202025—
+3K200541Hive™ Stand-alone Anterior Lumbar Interbody SystemHd Lifesciences, LLC20201—
+3K192115SABLE Expandable SpacerGlobus Medical, Inc.202037—
+3K191477AEON-C Stand Alone SystemHuvexel Co., Ltd.201910—
+3K191391HEDRON Lumbar SpacersGlobus Medical, Inc.201984—
+3K191243HEDRON Cervical SpacersGlobus Medical, Inc.201936—
+3K190885Elevation Spine Saber-C SystemElevation Spine201925—
+3K183249Tritanium X PL Expandable Posterior Lumbar Cage, Tritanium X TL Expandable Curved…Stryker Spine20196—
+3K183083Shoreline Cervical Interbody RT SystemSeaSpine Orthopedics Corporation201960—
+3K182284Tyber Medical PT Interbody SpacerTyber Medical, LLC20195—
+3K180909REVEL SpacersGlobus Medical, Inc.201837—
+3K173832InTice™-C Porous Ti Cervical Interbody SystemX-Spine Systems, Inc.201801
+4K261882Pisces-SC Standalone Cervical Interbody SystemOsseus Fusions Systems, LLC20260—
+4K261049Scala® TLSpineart SA20260—
+4K261408SABER-XA SystemElevation Spine20260—
+4K253420Admiral ACP System; Explorer TO System; Laminoplasty System; Manta Ray TDF Spacer…SeaSpine Orthopedics Corporation20260—
+4K252982CONDUIT™ ZERO-P™ VA Secured Spacer SystemAvalign Technologies, Inc.20260—
+4K260837VersaLift Expandable SystemLife Spine, Inc.20260—
+4K253401SCRIPT™ Implant SystemGlobus Medical, Inc.20260—
+4K260660SABER-C SystemElevation Spine20261—
+4K253260ORIO-3D Cage SystemSpineCraft20260—
+4K252205Curiteva Porous PEEK Cervical Interbody System; Curiteva Porous PEEK Lumbar Interbody…Curiteva, Inc.20260—
+4K254061Curiteva Porous PEEK Cervical Interbody Fusion SystemCuriteva, Inc.20260—
+4K250764SpineLinc Anterior Cervical Implant SystemLincotek Medical20250—
+4K250769Dakota LP SystemPrecision Spine, Inc.20250—
+4K250599ExcelsiusGPS™ InstrumentsGlobus Medical, Inc.20250—
+4K250540SABER-C SystemElevation Spine20252—
+4K250072CONDUIT™ SYNFIX™ Evolution Secured Spacer SystemAvalign Technologies, Inc.20251—
+4K250987aprevo® posterior/transforaminal lumbar interbody fusion deviceCarlsmed, Inc.20251—
+4K251617X-PAC® TLIF Expandable Posterior Cage System; X-PAC® LLIF Expandable Lateral Cage SystemExpanding Innovations, Inc.20250—
+4K250605EVOL® ha – Hyper C Cervical Interbody Fusion SystemCutting Edge Spine, LLC20250—
+4K243461Calibrate Interbody SystemsAlphatec Spine, Inc.20250—
+4K242517ProAM ACDF SystemPro Surgical, Inc.20240—
+4K242260aprevo® Cervical ACDF; aprevo® Cervical ACDF-X; aprevo® Cervical ACDF-X NO CAMCarlsmed, Inc.20243—
+4K233947KLIMT™ Expandable Lumbar Interbody Fusion (LIF) Cage SystemCtl Medical Corporation20240—
+4K2402503D Printed PEEK Interbody SystemNvision Biomedical Technologies, Inc.20240—