510(k) Report

Devices descending from P950002

1,681 later devices reach Bak Interbody Fusion System through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+3K240566Reef L Interbody System; WaveForm L Interbody SystemSeaSpine Orthopedics Corporation20245—
+3K240623Omnia Medical TiBrid™-SA SystemOmnia Medical, LLC20240—
+3K233509Zavation IBF System, Zavation Varisync Plate System and Varisync Spacer System…Zavation Medical Products, LLC20241—
+3K233075“BioGend” Interbody Fusion System 001 CageBiogend Therapeutics Co., Ltd.20240—
+3K231715MONDRIAN™ Anterior Lumbar Plate SystemCtl Medical Corporation20240—
+3K233735ADIRA™ Lateral Plate SystemGlobus Medical, Inc.20240—
+3K231743F3D Lateral Lumbar Interbody System, CL5 Lateral Lumbar Interbody System, and Oro…Corelink, LLC20233—
+3K232345ATEC Posterior Navigated Disc Prep InstrumentsAlphatec Spine, Inc.20232—
+3K231704Pro-Link® & Pro-Link® Ti Barbs Cervical Spacer SystemLife Spine, Inc.20230—
+3K232504Calibrate CCX Interbody SystemAlphatec Spine, Inc.202311
+3K230607SPICCA Cervical Fusion CagesSouthern Medical (Pty), Ltd.20230—
+3K221894Lumbar Expandable lnterbody Spacers -Additional Indications/ImplantsGlobus Medical, Inc.20232—
+3K231241NanoHive Medical Lumbar Interbody SystemNanoHive Medical, LLC20230—
+3K231199Solar Lumbar Interbody Fusion SystemDegen Medical20235—
+3K230894NuVasive Modulus ALIF SystemNu Vasive, Incorporated20234—
+3K230329F3D Interbody SystemCorelink, LLC20230—
+3K230936Anatomic PEEK™ Cervical Fusion System with NanotechnologyNanovis, LLC20230—
+3K220513NITRO Interbody Fusion Cage System FamilyCtl Medical Corporation20230—
+3K223043The Integrity Spine Core SystemIntegrity Spine20230—
+3K223231Ti-Largo Cervical Interbody SystemFlospine20230—
+3K221490Tritanium C Anterior Cervical Cage, Tritanium PL Cage, Tritanium TL Curved Posterior…Stryker Spine20231—
+3K223413Pisces™-SA STANDALONE ALIF Interbody SystemOsseus Fusion Systems20233—
+3K222041CYGNUS-C Standalone ACIF SystemGS Medical Co., Ltd.20231—
+3K223146EVOLUTION SPINE Interbody SystemEvolution Spine20239—
+3K220296Manta Ray TDF SpacerSeaSpine Orthopedics Corporation20231—
+3K223494CD Horizon Spinal SystemMedtronic202317—
+3K222554EL CAPITAN Anterior Lumbar Interbody FusionAstura Medical20235—
+3K223654Medussa-PL CageMedyssey USA, Inc.20220—
+3K2136534CIS Black Marlin Plif Cage System, 4CIS Dolphin Tlif Cage SystemSolco Biomedical Company India Private Limited20220—
+3K223153Catalyft LS Expandable Interbody System with Titan nanoLOCK Surface TechnologyMedtronic Sofamor Danek USA, Inc.20220—
+3K221182Southern Transforaminal Lumbar Interbody Fusion (TLIF)Southern Medical (Pty), Ltd.20220—
+3K222009aprevo® anterior lumbar interbody fusion device with interfixationCarlsmed, Inc.202212—
+3K221545MectaLIF Anterior ExtensionMedacta International S.A.202226
+3K222270HEDRON Cervical Spacers, HEDRON Lumbar Spacers, SABLE Expandable Spacer, ExcelsiusGPS…Globus Medical, Inc.202223—
+3K221936Standalone ALIF Interbody Fusion SystemEminent Spine20222—
+3K222797X-Pac Expandable Lumbar Cage SystemExpanding Innovations, Inc.20221—
+3K222028IdentiTi™ Porous Ti Interbody System, IdentiTi™ NanoTec™ Interbody System, Transcend™…Alphatec Spine202228—
+3K213417Ghost Spacer SystemLife Spine, Inc.20220—
+3K213641MONDRIAN ALIF Cage with Supplementary Fixation PlateCtl Medical Corporation20221—
+3K222082aprevo® anterior and lateral lumbar interbody fusion devices, aprevo® transforaminal…Carlsmed, Inc.202211—
+3K213791Unispace SA Cervical CageEdisoninno Co., Ltd.20222—
+3K220523restor3d TiDAL Lumbar Interbody Fusion DeviceRestor3D20222—
+3K221180Anteralign (TM) Spinal System with Titan NanoLOCK Surface Technology Navigated InstrumentsMedtronic Sofamor Danek USA, Inc.20222—
+3K220115ANTARES 3DR Standalone Anterior Lumbar Interbody Fusion SystemMiRus, LLC20220—
+3K213118Dakota ALIF SystemPrecision Spine, Inc.20220—
+3K220655X-Pac Expandable Lumbar Cage SystemExpanding Innovations, Inc.20222—
+3K212498Stable-L Standalone Lumbar Interbody SystemNexus Spine, LLC20227—
+3K213980Peridot Spinal Interbody SystemGbs Commonwealth Co., Ltd.20224—
+3K213441PathLoc Lumbar Interbody Fusion Cage SystemL&K BIOMED Co., Ltd.20222—
+3K220096Genesys Spine 3DP Lumbar Interbody SystemGenesys Spine20220—
+3K214011Catalyft™ PL Expandable Interbody System Navigated Instruments, Anteralign™ TL Spinal…Medtronic Sofamor Danek USA, Inc.20221—
+3K212075ShurFit Lumbar Interbody SystemPrecision Spine, Inc.20211—
+3K212653Catalyft LS Expandable Interbody SystemMedtronic Sofamor Danek USA, Inc.202127
+3K210573Velofix SA Cervical CageU&I Corporation20211—
+3K212831MectaLIF ExtensionMedacta International S.A.20211—
+3K212389Advantage Lumbar System - ALIF, PLIF, DLIF, TLIFIntelivation, LLC20210—
+3K212562Idys-C ZP 3DTiClariance, SA20211—
+3K211689KEYSTONE PEEK Cage SystemShanghai Sanyou Medical Co, Ltd.20212—
+3K211769OneLIF Intervertebral Body Replacement SystemNovapproach Spine202112
+3K212070KMTI S141 Lumbar Interbody Fusion SystemKyocera Medical Technologies, Inc.20210—
+3K210090Impulse AM Interbody Fusion SystemDegen Medical20217—
+3K211873PSX Interbody SystemAlphatec Spine, Inc.202111—
+3K210382Blustone Synergy Diamond SA Cervical SystemBlustone Synergy, LLC20210—
+3K211442StealthStation Spinous Process ClampsMedtronic Navigation20212—
+3K203003Pantheon IBFDPantheon Spinal20210—
+3K210595SPIRA-T Oblique Posterior Lumbar Spacers, SPIRA-P Posterior Lumbar SpacersCamber Spine Technologies, LLC20213—
+3K203802X-Pac Expandable Lumbar Cage SystemExpanding Innovations, Inc.20213—
+3K210583SeaSpine WaveForm™ A Interbody SystemSeaSpine Orthopedics Corporation202114—
+3K210425Catalyft PL Expandable Interbody SystemMedtronic Sofamor Danek USA, Inc.2021561
+3K203311ChoiceSpine Blackhawk Ti Cervical Spacer SystemChoice Spine, LLC20213—
+3K201671A-Link ZAcuity Surgical Devices, LLC202125—
+3K203742IdentiTi ALIF Standalone Interbody SystemAlphatec Spine, Inc.202159—
+3K203520Blustone Synergy Interbody Fusion SystemBlustone Synergy, LLC20210—
+3K203038Toro-L Interbody Fusion SystemIntegrity Implants, Inc.20215—
+3K210359Hexanium TLIFSpinevision, S.A.S.20211—
+3K200551MectaLIF Transforaminal TiPEEKMedacta Inernational SA20214—
+3K202872Prase PEEK Anterior Cervical Interbody SpacerGbs Commonwealth Co., Ltd.20215—
+3K203129NexGen Standalone Anterior Cervical Discectomy and Fusion (ACDF) SystemPrecision Spine, Inc.20210—
+3K202495SIRION Lateral Lumbar Interbody FusionAstura Medical, LLC20216—
+3K202820Australis Anterior Lumbar Cage SystemPrism Surgical Designs Pty, Ltd.20200—
+3K201643ChoiceSpine Tiger Shark Cervical Spacer SystemChoice Spine, LLC20204—
+3K202034aprevo Intervertebral Body Fusion DeviceCarlsmed, Inc.202017—
+3K201193SeaSpine Spacer System NM (Hollywood, Hollywood VI, Pacifica, Redondo, Ventura), Vu…SeaSpine Orthopedics Corporation202018—
+3K201939GAIA Lumbar Interbody Fusion Device (LIFD) FamilyPrinterprezz20200—
+3K200953NuVasive® Cohere® Thoracolumbar Interbody SystemNu Vasive, Incorporated2020141—
+3K202190Oculus-SA Lumbar Cage SystemNeurostructures20200—
+3K201367FlareHawk TiHawk9 Interbody Fusion SystemIntegrity Implants, Inc.20202—
+3K201769Cavetto [MAX] Cervical Cage SystemNeurostructures, Inc.20200—
+3K200958MODULIF-A Anterior Lumbar Interbody Fusion SystemSpinal Stability, LLC20200—
+3K200592GS Medical AnyPlus PEEK Cage SystemGS Medical Co., Ltd.20206—
+3K201500Life Spine Plateau-A Ti Anterior Lumbar Spacer & Plateau-X Ti Lateral Lumbar SpacerLife Spine, Inc.20203—
+3K201087CORBEL SpacersGlobus Medical, Inc.202036—
+3K200879SeaSpine Meridian System, SeaSpine Regatta Lateral SystemSeaSpine Orthopedics Corporation202060—
+3K193457AUDERE Lumbar Spacer SystemMet One Technologies20201—
+3K200541Hive™ Stand-alone Anterior Lumbar Interbody SystemHd Lifesciences, LLC20201—
+3K193153SPIRA-C Integrated Fixation SystemCamber Spine Technologies20202—
+3K192145Galileo Vertebral Body Replacement DeviceBright Spine20201—
+3K192492EL CAPITAN Anterior Lumber Interbody SystemAstura Medical, LLC202010—
+3K192006SIRION Lateral Lumbar Interbody SystemAstura Medical, LLC202014—
+3K200048MectaLIF Anterior SimpleMedacta International S.A.20200—