510(k) Report

Devices descending from K012254

2,058 later devices reach VBR through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+6K213491Universal Pilot Guidance Instrument SystemCtl Medical Corporation20220—
+6K220711SeaSpine Meridian System, SeaSpine Meridian Anterior Plate SystemSeaSpine Orthopedics Corporation202210—
+6K213935PISCES-SA Standalone ALIF Interbody SystemOsseus Fusion Systems202212—
+6K220038Camber Spine Navigation SystemCamber Spine Technologies20220—
+6K212811Ti3Z Lumbar Interbody SystemZavation Medical Products, LLC20223—
+6K214006Invictus® Spinal Fixation SystemAlphatec Spine, Inc.202216—
+6K214047EL CAPITAN Anterior Lumbar Interbody Fusion SystemAstura Medical20223—
+6K202266Reliance Cervical IBF SystemReliance Medical Systems, LLC20223—
+6K213980Peridot Spinal Interbody SystemGbs Commonwealth Co., Ltd.20224—
+6K213441PathLoc Lumbar Interbody Fusion Cage SystemL&K BIOMED Co., Ltd.20222—
+6K220096Genesys Spine 3DP Lumbar Interbody SystemGenesys Spine20220—
+6K213470PERLA® TL Posterior Osteosynthesis SystemSpineart20222—
+6K212358Romero Cervical CageSpineup, Inc.20226—
+6K212088Integrity Implants Navigated InstrumentsIntegrity Implants, Inc.20210—
+6K212266FIX-C PEEK Anterior Cervical Interbody SystemJeil Medical Corporation20217—
+6K212904SeaSpine WaveForm C Interbody SystemSeaSpine Orthopedics Corporation202115—
+6K213359SeaSpine WaveForm, C Interbody SystemSeaSpine Orthopedics Corporation20217—
+6K212075ShurFit Lumbar Interbody SystemPrecision Spine, Inc.20211—
+6K212653Catalyft LS Expandable Interbody SystemMedtronic Sofamor Danek USA, Inc.202127
+6K211845Deploy Expandable Interbody SystemSouthern Spine, LLC20210—
+6K212853Cervical Stand-Alone SystemEminent Spine, LLC202118—
+6K212389Advantage Lumbar System - ALIF, PLIF, DLIF, TLIFIntelivation, LLC20210—
+6K212489BonOs Inject Bone Cement; NEO Pedicle Screw SystemNeo Medical SA20215—
+6K212825CoreLink Navigation InstrumentsCorelink, LLC20214—
+6K212562Idys-C ZP 3DTiClariance, SA20211—
+6K212520ProLift Micro Expandable Spacer SystemLife Spine, Inc.20216—
+6K211769OneLIF Intervertebral Body Replacement SystemNovapproach Spine202112
+6K210470C-CURVE Interbody Fusion DeviceMedicrea International SA20210—
+6K211903Shoreline Threaded TruProfile® PlateSeaSpine Orthopedics Corporation20217—
+6K210090Impulse AM Interbody Fusion SystemDegen Medical20217—
+6K211501Advantage-C PEEK Cervical lnterbody Fusion DeviceLntelivation, LLC20211—
+6K210800IO Expandable Lumbar Interbody Fusion SystemMiRus, LLC20212—
+6K202836GX Navigation Instrument SystemLife Spine, Inc.20211—
+6K212066Adena-Zina SystemShanghai Sanyou Medical Co, Ltd.20213—
+6K210521DEXA-C Cervical Interbody SystemAurora Spine, Inc.20210—
+6K210497SeaSpine Spacer System NM (Hollywood, Hollywood VI, Pacifica, Redondo, Ventura), Vu…SeaSpine Orthopedics Corporation202139—
+6K210044Crystal Spinal System & Vertu Spinal System, Lucent Spinal System, Zeus Spinal System…Spinal Elements, Inc.20211—
+6K211306LabyrinthZavation Medical Products, LLC20213—
+6K201737Posterior Spinal Fixation SystemShanghai Reach Medical Instrument Co, Ltd.20211—
+6K210595SPIRA-T Oblique Posterior Lumbar Spacers, SPIRA-P Posterior Lumbar SpacersCamber Spine Technologies, LLC20213—
+6K211323ASTRA Spine SystemSpinecraft, LLC202112—
+6K210583SeaSpine WaveForm™ A Interbody SystemSeaSpine Orthopedics Corporation202114—
+6K211057LigaPASS® Spinal System, CD Horizon™ Spinal SystemMedtronic, Inc.20211—
+6K210306GII Spinal Fixation SystemColigne AG20210—
+6K202458BonOs Inject, Pedicle screw kits, Cement pusherOsartis GmbH20216—
+6K210874Reliance Spinal Screw SystemReliance Medical Systems, LLC20212—
+6K210439NuVasive MOD-EX XLIF Interbody SystemNu Vasive, Incorporated20214—
+6K201671A-Link ZAcuity Surgical Devices, LLC202125—
+6K210061ProLift Lateral HELO FixatedLife Spine, Inc.20213—
+6K210427M.U.S.T. Midline Cortical (MC) Screw SystemMedacta International S.A.20210—
+6K210539CoreLink Midline Fixation SystemCorelink, LLC20214—
+6K203742IdentiTi ALIF Standalone Interbody SystemAlphatec Spine, Inc.202159—
+6K210716CarboClear X Pedicle Screw System, CarboClear X Navigated InstrumentsCarboFix Orthopedics, Ltd.20218—
+6K203816DeGen Navigated InstrumentationDegen Medical20211—
+6K203038Toro-L Interbody Fusion SystemIntegrity Implants, Inc.20215—
+6K210472SPINEART Navigation Instrument SystemSpineart20215—
+6K203361ProLift Wedge Expandable Spacer SystemLife Spine, Inc.20211—
+6K210359Hexanium TLIFSpinevision, S.A.S.20211—
+6K201420Republic Spine Dark Star Spinal SystemRepublic Spine, LLC20212—
+6K202872Prase PEEK Anterior Cervical Interbody SpacerGbs Commonwealth Co., Ltd.20215—
+6K203482M.U.S.T. Pedicle Screw Extension and Long Tab ImplantsMedacta International S.A.20215—
+6K203153CREO Stabilization System, Navigation Instruments, ExcelsiusGPSGlobus Medical, Inc.20211—
+6K203506PERLA® TL posterior osteosynthesis systemSpineart202132
+6K203129NexGen Standalone Anterior Cervical Discectomy and Fusion (ACDF) SystemPrecision Spine, Inc.20210—
+6K203201NuVasive Thoracolumbar Interbody Systems: CoRoent Thoracolumbar System, CoRoent XL…Nu Vasive, Incorporated202194—
+6K200458Tailored-C Cervical Interbody Fusion SystemBespoke Technologies20203—
+6K201643ChoiceSpine Tiger Shark Cervical Spacer SystemChoice Spine, LLC20204—
+6K203125Invictus™ OCT Spinal Fixation SystemAlphatec Spine, Inc.20200—
+6K201755WaveForm L Interbody System, WaveForm TO Interbody System, WaveForm TA Interbody SystemSeaSpine Orthopedics Corporation202017—
+6K203367LineSider™ Spinal SystemIntegrity Implants, Inc.202054
+6K202034aprevo Intervertebral Body Fusion DeviceCarlsmed, Inc.202017—
+6K203317CarboClear X Pedicle Screw SystemCarboFix Orthopedics, Ltd.20209—
+6K201692NuVasive Modulus XLIF Interbody SystemNu Vasive, Incorporated202067—
+6K193000Hexanium® ACIFSpinevision, S.A.S.202014—
+6K201939GAIA Lumbar Interbody Fusion Device (LIFD) FamilyPrinterprezz20200—
+6K200953NuVasive® Cohere® Thoracolumbar Interbody SystemNu Vasive, Incorporated2020141—
+6K202190Oculus-SA Lumbar Cage SystemNeurostructures20200—
+6K201820NuVasive Thoracolumbar Interbody Systems: CoRoent Thoracolumbar System, CoRoent XL…Nu Vasive, Incorporated2020156—
+6K201367FlareHawk TiHawk9 Interbody Fusion SystemIntegrity Implants, Inc.20202—
+6K201646Shoreline ACS (Anterior Cervical System)SeaSpine Orthopedics Corporation202020—
+6K201721TruLift Expandable Spacer SystemLife Spine, Inc.20205—
+6K201769Cavetto [MAX] Cervical Cage SystemNeurostructures, Inc.20200—
+6K192863MONDRIAN Lumbar Interbody Fusion Cage SystemCtl Medical Corporation20203—
+6K201362CD Horizon™ Fenestrated Screw Set, CD Horizon™ Spinal System, Kyphon™ HV-R™ Bone CementMedtronic202038—
+6K201006K2M Navigation InstrumentsK2m, Inc.20200—
+6K201087CORBEL SpacersGlobus Medical, Inc.202036—
+6K201648Sterispine™ PSSafe Orthopaedics202011
+6K200969NEXXT MATRIXX SystemNexxt Spine, LLC20200—
+6K193457AUDERE Lumbar Spacer SystemMet One Technologies20201—
+6K200541Hive™ Stand-alone Anterior Lumbar Interbody SystemHd Lifesciences, LLC20201—
+6K193153SPIRA-C Integrated Fixation SystemCamber Spine Technologies20202—
+6K200245EXPEDIUM® Spine System; EXPEDIUM VERSE® Spine SystemMedos International Sàrl202012—
+6K200070ARx Spinal SystemLife Spine, Inc.20209—
+6K200338ProLift Lateral FixatedLife Spine, Inc.20205—
+6K200312Tryptik TiSpineart20202—
+6K200552EVOS Lumbar Interbody SystemCutting Edge Spine, LLC20200—
+6K193593NuVasive 3DP Interfixated ALIF SystemNu Vasive, Incorporated2020157—
+6K200543NEXXT MATRIXX Stand Alone Cervical-Turn Lock (-TL) SystemNexxt Spine, LLC202072—
+6K192897icotec Cervical CageIcotec AG20201—
+6K193418SeaSpine Skipjack SystemSeaSpine Orthopedics Corporation20204—