510(k) Report

Devices descending from K103382

554 later devices reach Intercontinental Plate-Spacer through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+4K222082aprevo® anterior and lateral lumbar interbody fusion devices, aprevo® transforaminal…Carlsmed, Inc.202211—
+4K220478NuVasive MOD-EX XLIF Interbody System, NuVasive MOD-EX XLIF Plated 2.0 Interbody SystemNu Vasive, Incorporated20222—
+4K220581Zavation eZspand Interbody SystemZavation Medical Products, LLC20224—
+4K220115ANTARES 3DR Standalone Anterior Lumbar Interbody Fusion SystemMiRus, LLC20220—
+4K213355Toro-L Interbody Fusion SystemIntegrity Implants, Inc.20224—
+4K212980Tesera-k ALIF SystemKyocera Medical Technologies, Inc.20222—
+4K203714NuVasive Thoracolumbar Interbody Systems: NuVasive CoRoent Thoracolumbar System…Nu Vasive, Incorporated202166—
+4K212904SeaSpine WaveForm C Interbody SystemSeaSpine Orthopedics Corporation202115—
+4K213359SeaSpine WaveForm, C Interbody SystemSeaSpine Orthopedics Corporation20217—
+4K212853Cervical Stand-Alone SystemEminent Spine, LLC202118—
+4K211805IdentiTi Porous Ti Interbody System, Transcend PEEK Interbody System, IdentiTi NanoTec…Alphatec Spine, Inc.202138—
+4K211903Shoreline Threaded TruProfile® PlateSeaSpine Orthopedics Corporation20217—
+4K210800IO Expandable Lumbar Interbody Fusion SystemMiRus, LLC20212—
+4K210497SeaSpine Spacer System NM (Hollywood, Hollywood VI, Pacifica, Redondo, Ventura), Vu…SeaSpine Orthopedics Corporation202139—
+4K210595SPIRA-T Oblique Posterior Lumbar Spacers, SPIRA-P Posterior Lumbar SpacersCamber Spine Technologies, LLC20213—
+4K211258Endoskeleton TC Interbody System, Endoskeleton TCS Interbody System, Endoskeleton TA…Medtronic Sofamor Danek USA, Inc.202175—
+4K210214NuVasive Modulus Expandable Posterior Lumbar MOD-EX PL Interbody SystemNu Vasive, Incorporated20213—
+4K210439NuVasive MOD-EX XLIF Interbody SystemNu Vasive, Incorporated20214—
+4K201671A-Link ZAcuity Surgical Devices, LLC202125—
+4K203520Blustone Synergy Interbody Fusion SystemBlustone Synergy, LLC20210—
+4K203444BEE HA CageNGMedical GmbH20211—
+4K210271NuVasive Modulus ALIF SystemNu Vasive, Incorporated20215—
+4K202398Ti3Z Cervical Interbody SystemZavation Medical Products, LLC20219—
+4K203153CREO Stabilization System, Navigation Instruments, ExcelsiusGPSGlobus Medical, Inc.20211—
+4K201755WaveForm L Interbody System, WaveForm TO Interbody System, WaveForm TA Interbody SystemSeaSpine Orthopedics Corporation202017—
+4K202034aprevo Intervertebral Body Fusion DeviceCarlsmed, Inc.202017—
+4K201193SeaSpine Spacer System NM (Hollywood, Hollywood VI, Pacifica, Redondo, Ventura), Vu…SeaSpine Orthopedics Corporation202018—
+4K202305Zavation IBF SystemZavation Medical Products, LLC20209—
+4K200991EVOL Spinal Interbody SystemCutting Edge Spine, LLC20200—
+4K200541Hive™ Stand-alone Anterior Lumbar Interbody SystemHd Lifesciences, LLC20201—
+4K193418SeaSpine Skipjack SystemSeaSpine Orthopedics Corporation20204—
+4K192132SeaSpine Beachside SystemSeaSpine Orthopedics Corporation2019591
+4K191621ChoiceSpine Octane A/T/P Spinal Implant System, ChoiceSpine Cervical Interbody Spacer…Choice Spine, LLC20194—
+4K191311ATEC Lateral Interbody SystemAlphatec Spine, Inc.201978—
+4K191091Rampart One Lumbar Interbody Fusion SystemSpineology, Inc.20191—
+4K183083Shoreline Cervical Interbody RT SystemSeaSpine Orthopedics Corporation201960—
+4K182284Tyber Medical PT Interbody SpacerTyber Medical, LLC20195—
+4K182746ATEC ALIF and LLIF Spacer SystemAlphatec Spine, Inc.2018110—
+4K181386NuVasive Brigade Lateral SystemNu Vasive, Incorporated2018158—
+4K180590Tyber Medical PT Interbody Spacer SystemTyber Medical, LLC20186—
+4K173832InTice™-C Porous Ti Cervical Interbody SystemX-Spine Systems, Inc.201801
+4K172816TiGer Shark™ SystemChoicespine, LP201859—
+4K172419Velofix™ TLIF CageU&I Corporation20172—
+4K173175Paramount Anterior Cervical Cage SystemSpine Wave, Inc.20170—
+4K171689ARTiC-L 3D Ti Spinal System with TiONIC Technology, ARTiC-XL 3D Ti Spinal System with…Medtronic Sofamor Danek USA, Inc.2017109—
+4K170119Calix Lumbar Spinal Implant SystemX-Spine Systems, Inc.201711
+4K171633NuVasive TLX Interbody SystemNu Vasive, Incorporated2017251—
+4K171686Choice Spine Hawkeye™ Vertebral Body Replacement (VBR) SystemChoicespine2017116—
+4K170962NuVasive® CoRoent® Thoracolumbar SystemNu Vasive, Incorporated2017304—
+4K163707NuVasive CoRoent Ti-C SystemNu Vasive, Incorporated201719—
+4K170592NuVasive BASE Interfixated Titanium SystemNu Vasive, Incorporated2017186—
+4K163230NuVasive Modulus XLIF Interbody SystemNu Vasive, Incorporated2017276—
+4K162138NuVasive CoRoent Small Ti-C SystemNu Vasive, Incorporated2016135—
+5K263049SABER-C SystemElevation Spine20260—
+5K261451ZSAlign Cervical Interbody SystemZSFab, Inc.20260—
+5K261205SPINEART Navigation Instrument SystemSpineart SA20260—
+5K261353Tesera-K Anterior Lumbar Interbody Fusion (ALIF) System; Tesera-K XL System; Lumbar…Kyocera Medical Technologies, Inc.20260—
+5K261020Symmetrix™ L Spinal SystemMedtronic Sofamor Danek USA, Inc.20260—
+5K254130C.A. Medical Interbody Fusion SystemC.A. Medical, LLC20260—
+5K253420Admiral ACP System; Explorer TO System; Laminoplasty System; Manta Ray TDF Spacer…SeaSpine Orthopedics Corporation20260—
+5K261279DeltaNEC Interbody SystemNexus Spine20260—
+5K261159Exceed® Biplanar Expandable Interbody SystemSpine Wave, Inc.20260—
+5K260385aprevo® anterior and lateral lumbar interbody system; aprevo® posterior and…Carlsmed, Inc.20260—
+5K253739SCRIPT™ Rods, CREO™ Stabilization System, REVERE® Stabilization System, REVERE® 4.5…Globus Medical, Inc.20260—
+5K250773Luna® Ti Interbody Fusion SystemSpinal Elements, Inc.20260—
+5K254061Curiteva Porous PEEK Cervical Interbody Fusion SystemCuriteva, Inc.20260—
+5K252610ZSFab Lumbar Interbody SystemZsfab, Inc.20251—
+5K252327CMORE® CT System; CMORE® CT System Navigated InstrumentsIcotec AG20251—
+5K250076Endeavor™ Stand-Alone Cervical IBF SystemInnovasis20250—
+5K251444Endoskeleton™ Interbody SystemsMedtronic Sofamor Danek USA, Inc.20250—
+5K250827aprevo® anterior lumbar interbody fusion device; aprevo® lateral lumbar interbody fusion…Carlsmed, Inc.20252—
+5K251080IdentiTi II Cervical Interbody SystemAlphatec Spine, Inc.20250—
+5K243816Testa TP Pivoting Spacer SystemSpine Wave, Inc.20250—
+5K251617X-PAC® TLIF Expandable Posterior Cage System; X-PAC® LLIF Expandable Lateral Cage SystemExpanding Innovations, Inc.20250—
+5K243386Ventris Intervertebral Body Fusion DeviceAcuity Surgical Devices, LLC20252—
+5K250669Adaptix™ Interbody System with Titan nanoLOCK™ Surface TechnologyMedtronic Sofamor Danek USA, Inc.20250—
+5K250521NanoBone® SBX Putty ; NanoBone® QDBiocomposites, Ltd.20250—
+5K243074Spectrum Spine Lumbar Cage SystemSpectrum Spine, Inc.20252—
+5K250556Porous Biologic ScaffoldVentris Medical20250—
+5K242771Tesera-k PL System and Tesera-k XL SystemKyocera Medical Technologies, Inc.20251—
+5K241783FortiVy™ OsteoVy™ Lumbar IBFVy Spine, LLC20250—
+5K250605EVOL® ha – Hyper C Cervical Interbody Fusion SystemCutting Edge Spine, LLC20250—
+5K241375IdentiTi Porous Ti Interbody System; IdentiTi NanoTec Interbody System; IdentiTi…Alphatec Spine20253—
+5K243706Mastergraft Matrix EXT; Mastergraft Strip; Mastergraft Putty; Mastergraft GranulesMedtronic Sofamor Danek, Inc.20250—
+5K241167BioSphere Putty; BioSphere MIS PuttySynergy Biomedical20240—
+5K242260aprevo® Cervical ACDF; aprevo® Cervical ACDF-X; aprevo® Cervical ACDF-X NO CAMCarlsmed, Inc.20243—
+5K241077DeGen Medical Patient Specific Implant (PSI) SystemDegen Medical20242—
+5K242829BluEX Lumbar Expandable Cage SystemL&K BIOMED Co., Ltd.20240—
+5K241477aprevo® anterior lumbar interbody fusion device with interfixationCarlsmed, Inc.20246—
+5K242826ProLift Wedge Expandable Spacer SystemLife Spine, Inc.20240—
+5K241487Interwedge® Standalone LateralFoundation Surgical Group, Inc.20241—
+5K242299NovaBone Putty - Synthetic Bioactive Bone GraftNovabone Products, LLC20241—
+5K242273Cove Putty, OsteoCove PuttySeaSpine Orthopedics Corporation202402
+5K241332aprevo® anterior and lateral lumbar interbody fusion device; aprevo® anterior lumbar…Carlsmed, Inc.20245—
+5K2402503D Printed PEEK Interbody SystemNvision Biomedical Technologies, Inc.20240—
+5K232996Iatrical Interbody Lumbar Fusion Systems (Model ALIF, Model TLIF, Model LLIF)Shanghai Iatrical-Ti Technologies CO, Ltd.20240—
+5K241328aprevo® Anterior and Lateral Lumbar Interbody Fusion device (ALIF/LLIF); aprevo®…Carlsmed, Inc.20240—
+5K241019aprevo® TLIF-C Articulating SystemCarlsmed20244—
+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—