510(k) Report

Devices descending from K120570

322 later devices reach Choice Spine Vertebral Body Replacement (VBR) Device System through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+5K254105Hive™ Standalone Cervical System and Hive™ C Interbody SystemNanoHive Medical, LLC20260—
+5K253876HEDRON™ Cervical Spacers (HEDRON C-MIS™ Spacer)Globus Medical, Inc.20251—
+5K250560BEE HANGMedical GmbH20250—
+5K251444Endoskeleton™ Interbody SystemsMedtronic Sofamor Danek USA, Inc.20250—
+5K250335IVA & AEON Cervical and Lumbar Cage SystemK&J Consulting20250—
+5K251431FIX-C PEEK ACIF SA SystemJeil Medical Corporation20250—
+5K251459OneLIF™ Interbody Fusion SystemNovapproach Spine, LLC20250—
+5K243074Spectrum Spine Lumbar Cage SystemSpectrum Spine, Inc.20252—
+5K241783FortiVy™ OsteoVy™ Lumbar IBFVy Spine, LLC20250—
+5K242260aprevo® Cervical ACDF; aprevo® Cervical ACDF-X; aprevo® Cervical ACDF-X NO CAMCarlsmed, Inc.20243—
+5K241164IB3D™ PL Spinal SystemMedicrea International S.A.S. (Medtronic)202412
+5K240830Reef TO/TA System; Regatta Lateral System; Explorer TO System; WaveForm C Interbody…Orthofix Medical, Inc.20242—
+5K241466Shoreline ACS Interbody System; Shoreline RT Interbody System; Regatta Lateral System…SeaSpine Orthopedics Corporation20243—
+5K240838Spectrum Spine Cervical Cage SystemSpectrum Spine, Inc.20244—
+5K240566Reef L Interbody System; WaveForm L Interbody SystemSeaSpine Orthopedics Corporation20245—
+5K234087restor3d TIDAL Lumbar Interbody Fusion SystemRestor3D20240—
+5K233414Shoreline ACS Interbody System; Shoreline RT Interbody SystemSeaSpine Orthopedics Corporation20238—
+5K232504Calibrate CCX Interbody SystemAlphatec Spine, Inc.202311
+5K221894Lumbar Expandable lnterbody Spacers -Additional Indications/ImplantsGlobus Medical, Inc.20232—
+5K230731Zavation ALIF SystemZavation Medical Products, LLC20232—
+5K230936Anatomic PEEK™ Cervical Fusion System with NanotechnologyNanovis, LLC20230—
+5K221324ENZA-O Titanium Lateral Anterior Lumbar Interbody Fusion (ALIF)Camber Spine Technologies20230—
+5K223326Axiom PSR SystemRestor3D202301
+5K223837SPIRA®-C Integrated Fixation SystemCamber Spine Technologies20230—
+5K213030Curiteva Porous PEEK Cervical Interbody Fusion SystemCuriteva, Inc.20233—
+5K220296Manta Ray TDF SpacerSeaSpine Orthopedics Corporation20231—
+5K222554EL CAPITAN Anterior Lumbar Interbody FusionAstura Medical20235—
+5K223190Hive™ Standalone Cervical SystemNanoHive Medical, LLC20225—
+5K222973IdentiTi and Transcend Interbody Systems: IndentiTi Cervical Porous Ti Interbody System…Alphatec Spine, Inc.202213—
+5K222732WaveForm A Interbody SystemSeaSpine Orthopedics Corporation20229—
+5K214010Anteralign Spinal System with Titan nanoLOCK Surface TechnologyMedtronic Sofamor Danek USA202249—
+5K214047EL CAPITAN Anterior Lumbar Interbody Fusion SystemAstura Medical20223—
+5K211417F3D-C2 Cervical Stand-Alone SystemCorelink, LLC20223—
+5K212524Anteralign Spinal System with Titan nanoLOCK Surface TechnologyMedtronic Sofamor Danek USA, Inc.202155—
+5K211873PSX Interbody SystemAlphatec Spine, Inc.202111—
+5K210382Blustone Synergy Diamond SA Cervical SystemBlustone Synergy, LLC20210—
+5K203003Pantheon IBFDPantheon Spinal20210—
+5K203520Blustone Synergy Interbody Fusion SystemBlustone Synergy, LLC20210—
+5K203444BEE HA CageNGMedical GmbH20211—
+5K203278INDEPENDENCE Spacers, HEDRON IA, MAGNIFY-S Spacers, MONUMENT Spacers, InterContinental…Globus Medical, Inc.202135—
+5K202398Ti3Z Cervical Interbody SystemZavation Medical Products, LLC20219—
+5K203207Omnia Medical TiBrid-SAOmnia Medical, LLC202012
+5K202820Australis Anterior Lumbar Cage SystemPrism Surgical Designs Pty, Ltd.20200—
+5K203076Mecta-C Stand Alone ExtensionMedacta International S.A.20200—
+5K202065DOLOMITE Anterior Cervical Stabilization SystemAstura Medical, LLC20203—
+5K202305Zavation IBF SystemZavation Medical Products, LLC20209—
+5K201073Seaspine WaveForm C Interbody SystemSeaSpine Orthopedics Corporation202017—
+5K201267Adaptix Interbody System with Titan nanoLOCK Surface TechnologyMedtronic Sofamor Danek202079—
+5K201585Monterey AL Interbody SystemStryker Corporation202044
+5K200087F3D Cervical Stand-Alone Interbody Fusion SystemCorelink, LLC202025—
+5K192115SABLE Expandable SpacerGlobus Medical, Inc.202037—
+5K191477AEON-C Stand Alone SystemHuvexel Co., Ltd.201910—
+5K191391HEDRON Lumbar SpacersGlobus Medical, Inc.201984—
+5K191243HEDRON Cervical SpacersGlobus Medical, Inc.201936—
+5K190885Elevation Spine Saber-C SystemElevation Spine201925—
+5K183249Tritanium X PL Expandable Posterior Lumbar Cage, Tritanium X TL Expandable Curved…Stryker Spine20196—
+5K183083Shoreline Cervical Interbody RT SystemSeaSpine Orthopedics Corporation201960—
+5K180909REVEL SpacersGlobus Medical, Inc.201837—
+5K173832InTice™-C Porous Ti Cervical Interbody SystemX-Spine Systems, Inc.201801
+6K261882Pisces-SC Standalone Cervical Interbody SystemOsseus Fusions Systems, LLC20260—
+6K261049Scala® TLSpineart SA20260—
+6K261408SABER-XA SystemElevation Spine20260—
+6K261353Tesera-K Anterior Lumbar Interbody Fusion (ALIF) System; Tesera-K XL System; Lumbar…Kyocera Medical Technologies, Inc.20260—
+6K261020Symmetrix™ L Spinal SystemMedtronic Sofamor Danek USA, Inc.20260—
+6K253420Admiral ACP System; Explorer TO System; Laminoplasty System; Manta Ray TDF Spacer…SeaSpine Orthopedics Corporation20260—
+6K252982CONDUIT™ ZERO-P™ VA Secured Spacer SystemAvalign Technologies, Inc.20260—
+6K260810Anteralign LS coverplateTyber Medical, LLC20260—
+6K260837VersaLift Expandable SystemLife Spine, Inc.20260—
+6K253401SCRIPT™ Implant SystemGlobus Medical, Inc.20260—
+6K260660SABER-C SystemElevation Spine20261—
+6K253260ORIO-3D Cage SystemSpineCraft20260—
+6K252240Spectrum Spine Cervical Cage System; Spectrum Spine Lumbar Cage SystemSpectrum Spine20260—
+6K254061Curiteva Porous PEEK Cervical Interbody Fusion SystemCuriteva, Inc.20260—
+6K253577IB3D™ PL Spinal System (A24000000 / IB3D Universal Implant Inserter)Medicrea International S.A.S. (Medtronic)20250—
+6K250764SpineLinc Anterior Cervical Implant SystemLincotek Medical20250—
+6K250599ExcelsiusGPS™ InstrumentsGlobus Medical, Inc.20250—
+6K253377Expandable Titanium PLIF/TLIF SystemSpectrum Spine, Inc.20250—
+6K250540SABER-C SystemElevation Spine20252—
+6K250072CONDUIT™ SYNFIX™ Evolution Secured Spacer SystemAvalign Technologies, Inc.20251—
+6K250827aprevo® anterior lumbar interbody fusion device; aprevo® lateral lumbar interbody fusion…Carlsmed, Inc.20252—
+6K250987aprevo® posterior/transforaminal lumbar interbody fusion deviceCarlsmed, Inc.20251—
+6K251644ProAM ALIF SystemPro Surgical, Inc.20250—
+6K251617X-PAC® TLIF Expandable Posterior Cage System; X-PAC® LLIF Expandable Lateral Cage SystemExpanding Innovations, Inc.20250—
+6K250669Adaptix™ Interbody System with Titan nanoLOCK™ Surface TechnologyMedtronic Sofamor Danek USA, Inc.20250—
+6K243461Calibrate Interbody SystemsAlphatec Spine, Inc.20250—
+6K241375IdentiTi Porous Ti Interbody System; IdentiTi NanoTec Interbody System; IdentiTi…Alphatec Spine20253—
+6K242517ProAM ACDF SystemPro Surgical, Inc.20240—
+6K233947KLIMT™ Expandable Lumbar Interbody Fusion (LIF) Cage SystemCtl Medical Corporation20240—
+6K242364IdentiTi™ II Interbody SystemAlphatec Spine, Inc.20244—
+6K2402503D Printed PEEK Interbody SystemNvision Biomedical Technologies, Inc.20240—
+6K234035COSINE™ SpacerGlobus Medical, Inc.20240—
+6K241605Adaptix™ PEEK Interbody System with Nanotechnology; Capstone Control™ PEEK Spinal System…Nanovis, LLC20240—
+6K241846E3D™-C Interbody SystemEvolution Spine20246—
+6K240749PILLAR SA Ti Spacer System (82-XXX)Orthofix, Inc.202402
+6K240368E3D™-A Interbody SystemEvolution Spine20247—
+6K240126ProAM ALIF SystemPro Surgical, Inc.20242—
+6K240623Omnia Medical TiBrid™-SA SystemOmnia Medical, LLC20240—
+6K233640Segmental Plating System (SPS);IdentiTi SPS Interbody System;IdentiTi NanoTec SPS…Alphatec Spine, Inc.20245—
+6K233735ADIRA™ Lateral Plate SystemGlobus Medical, Inc.20240—
+6K233694Meridian Interbody System; WaveForm A Interbody SystemSeaSpine Orthopedics Corporation20248—