510(k) Report

Devices descending from K922543

640 later devices reach Z-Plate Anterior Fixation System through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+5K133575Spinevision Lumis Cannulated Pedicle Screw Fixation System, Spinevision U.L.I.S. Pedicle…Spinevision S.A.20143—
+5K131810Osseus Black Diamond Pedicle Screw SystemOsseus Fusion Systems, LLC201314—
+5K121728Tiger Spine SystemCorelink, LLC201250—
+5K121172Reform Pedicle Screw SystemSpinal USA201233—
+5K121016Range Spinal System (Mesa and Denali)K2m, Inc.201238—
+5K121020Viper SystemDepuy Spine, Inc.201294—
+5K120696Tiger Spine SystemCorelink, LLC201241—
+5K080767Conquest Spinal SystemLife Spine200821—
+6K262828KHEIRON® Spinal Fixation System, including patient specific K-RODS.M.A.I.O20260—
+6K261309Palisades™ Buttress Plate SystemBethesda Medical Devices, LLC20260—
+6K261020Symmetrix™ L Spinal SystemMedtronic Sofamor Danek USA, Inc.20260—
+6K261112CastleLoc-P Anterior Cervical Plate SystemL&K BIOMED Co., Ltd.20260—
+6K253401SCRIPT™ Implant SystemGlobus Medical, Inc.20260—
+6K252432Flex-Z™ Cervical CageSpinepoint, LLC20260—
+6K252205Curiteva Porous PEEK Cervical Interbody System; Curiteva Porous PEEK Lumbar Interbody…Curiteva, Inc.20260—
+6K253990KHEIRON® Spinal Fixation System, including patient specific K-RODS.M.A.I.O20262—
+6K250769Dakota LP SystemPrecision Spine, Inc.20250—
+6K250599ExcelsiusGPS™ InstrumentsGlobus Medical, Inc.20250—
+6K252346OLYMPIC Posterior Spinal Fixation System; MASADA Modular Spinal Fixation SystemAstura Medical20250—
+6K253249TriALTIS™ Spine SystemMedos International SARL20251—
+6K252737DeGen Medical Latitude-C AM Cervical Interbody Fusion SystemDegen Medical20250—
+6K252437JAZZ Spinal SystemImplanet20250—
+6K250827aprevo® anterior lumbar interbody fusion device; aprevo® lateral lumbar interbody fusion…Carlsmed, Inc.20252—
+6K251080IdentiTi II Cervical Interbody SystemAlphatec Spine, Inc.20250—
+6K251431FIX-C PEEK ACIF SA SystemJeil Medical Corporation20250—
+6K251617X-PAC® TLIF Expandable Posterior Cage System; X-PAC® LLIF Expandable Lateral Cage SystemExpanding Innovations, Inc.20250—
+6K251459OneLIF™ Interbody Fusion SystemNovapproach Spine, LLC20250—
+6K243934Stable-L Lumbar Interbody SystemNexus Spine, LLC20250—
+6K241783FortiVy™ OsteoVy™ Lumbar IBFVy Spine, LLC20250—
+6K241375IdentiTi Porous Ti Interbody System; IdentiTi NanoTec Interbody System; IdentiTi…Alphatec Spine20253—
+6K243259MASADA Modular Spinal Fixation SystemAstura Medical20250—
+6K243635aprevo® anterior lumbar interbody fusion device with interfixationCarlsmed, Inc.20245—
+6K241077DeGen Medical Patient Specific Implant (PSI) SystemDegen Medical20242—
+6K242147Calibrate LTX Interbody System; Calibrate NanoTec LTX Interbody SystemAlphatec Spine, Inc.20241—
+6K234035COSINE™ SpacerGlobus Medical, Inc.20240—
+6K241164IB3D™ PL Spinal SystemMedicrea International S.A.S. (Medtronic)202412
+6K240180Orthopeasia Spinal Fixation SystemOrthopeasia Co., Ltd.20240—
+6K241846E3D™-C Interbody SystemEvolution Spine20246—
+6K240368E3D™-A Interbody SystemEvolution Spine20247—
+6K240392JAZZ Spinal SystemImplanet20241—
+6K233640Segmental Plating System (SPS);IdentiTi SPS Interbody System;IdentiTi NanoTec SPS…Alphatec Spine, Inc.20245—
+6K234048M.U.S.T. Pedicle Screw System - ExtensionMedacta International S.A.20241—
+6K233594Genesys Spine 3DP AIS-C II Cervical Interbody SystemGenesys Spine20232—
+6K230639Align Cervical Interbody Fusion SystemAcuity Surgical Devices, LLC20232—
+6K232504Calibrate CCX Interbody SystemAlphatec Spine, Inc.202311
+6K231658VEOS Spinal Fixation SystemSpineway20230—
+6K232044Invictus Robotic Navigation InstrumentsAlphatec Spine, Inc.20233—
+6K232275Invictus® Spinal Fixation SystemAlphatec Spine, Inc.202311—
+6K232097IdentiTi ALIF Interbody SystemsAlphatec Spine, Inc.202371
+6K231766Skyway Anterior Cervical Plate SystemKyocera Medical Technologies Inc. (KMTI)20233—
+6K231840CastleLoc-S Posterior Cervical Fixation SystemL&K BIOMED Co., Ltd.20230—
+6K231841PathLoc SI Joint Fusion SystemL&K BIOMED Co., Ltd.20231—
+6K231438Calibrate PSX Interbody System, Calibrate NanoTec PSX Interbody SystemAlphatec Spine, Inc.20237—
+6K230936Anatomic PEEK™ Cervical Fusion System with NanotechnologyNanovis, LLC20230—
+6K222229Advanced LumFix Spinal Fixation SystemCG Bio Co., Ltd.20232—
+6K223335SIRION Lateral Lumbar Interbody SystemAstura Medical20230—
+6K223611Calibrate LTX Interbody SystemAlphatec Spine, Inc.20237—
+6K223521ZESPIN SI Joint Fusion SystemAegis Spine, Inc.20232—
+6K222455Calibrate LTX Interbody SystemAlphatec Spine, Inc.20228—
+6K222473EXPEDIUM® Spine System, EXPEDIUM VERSE® Spine System: ALTALYNE™ Ultra RodsMedos-International Sarl20221—
+6K221050ZESPIN SI Joint Fusion System, Paeon Posterior Cervical Fixation System, Paeon Anterior…Aegis Spine, Inc.20226—
+6K220523restor3d TiDAL Lumbar Interbody Fusion DeviceRestor3D20222—
+6K221180Anteralign (TM) Spinal System with Titan NanoLOCK Surface Technology Navigated InstrumentsMedtronic Sofamor Danek USA, Inc.20222—
+6K220341ARx Modular Spinal SystemLife Spine, Inc.20221—
+6K214010Anteralign Spinal System with Titan nanoLOCK Surface TechnologyMedtronic Sofamor Danek USA202249—
+6K220374EXPEDIUM VERSE® Fenestrated Screw System (Sterile Fenestrated Screws)Medos International SARL20229—
+6K214011Catalyft™ PL Expandable Interbody System Navigated Instruments, Anteralign™ TL Spinal…Medtronic Sofamor Danek USA, Inc.20221—
+6K211417F3D-C2 Cervical Stand-Alone SystemCorelink, LLC20223—
+6K212980Tesera-k ALIF SystemKyocera Medical Technologies, Inc.20222—
+6K212653Catalyft LS Expandable Interbody SystemMedtronic Sofamor Danek USA, Inc.202127
+6K211935ORIO-Ti Intervertebral Body Fusion Cage SystemSpinecraft, LLC20210—
+6K211805IdentiTi Porous Ti Interbody System, Transcend PEEK Interbody System, IdentiTi NanoTec…Alphatec Spine, Inc.202138—
+6K210090Impulse AM Interbody Fusion SystemDegen Medical20217—
+6K212185Golden Isles Pedicle Screw SystemIntelivation, LLC20210—
+6K211873PSX Interbody SystemAlphatec Spine, Inc.202111—
+6K201671A-Link ZAcuity Surgical Devices, LLC202125—
+6K210539CoreLink Midline Fixation SystemCorelink, LLC20214—
+6K200919Idys ALIF 3DTiClariance20210—
+6K202032Idys LLIF 3DTiClariance, Sas20210—
+6K210155Duo Expandable Interbody Fusion SystemSpineology, Inc.20210—
+6K203278INDEPENDENCE Spacers, HEDRON IA, MAGNIFY-S Spacers, MONUMENT Spacers, InterContinental…Globus Medical, Inc.202135—
+6K201287Impulse Interbody Fusion SystemDegen Medical20208—
+6K202820Australis Anterior Lumbar Cage SystemPrism Surgical Designs Pty, Ltd.20200—
+6K202812IdentiTi Cervical Standalone Interbody SystemAlphatec Spine, Inc.202067—
+6K202587ATEC Lateral Interbody SystemAlphatec Spine, Inc.202039—
+6K201500Life Spine Plateau-A Ti Anterior Lumbar Spacer & Plateau-X Ti Lateral Lumbar SpacerLife Spine, Inc.20203—
+6K200920Idys ALIF ZP 3DTiClariance, Sas20203—
+6K192938Invictus™ Spinal Fixation SystemAlphatec Spine, Inc.201969—
+6K192026Peridot Intervertebral body fusion SystemGbs Commonwealth Co., Ltd.20196—
+6K192168Idys ALIF ZP 3DTiClariance, Sas20195—
+6K191134IB3D AlifMedicrea International SA20191—
+6K192121Black Diamond Pedicle Screw SystemOsseus Fusion Systems201913—
+6K191066CD Horizon™ Astute™ Spinal SystemMedtronic Sofamor Danek USA, Inc.201921—
+6K191100ExcelsiusGPS Spine 1.1 Interbody ModuleGlobus Medical, Inc.201942—
+6K191263Idys ALIF TiVacClariance, Sas20190—
+6K190165Capstone Control™ Spinal SystemMedtronic Sofamor Danek USA, Inc.20196—
+6K190376PASS LP Spinal SystemMedicrea International SA201915
+6K181397DualXInnovasive, Inc.201815—
+6K181339Altus Spine Pedicle Screw SystemAltus Partners, LLC20186—
+6K180071STYLO Interbody Fusion DeviceLegend Spine Technologies20180—