510(k) Report

Devices descending from K000536

297 later devices reach Synthes Anterior CSLP System through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+3K252346OLYMPIC Posterior Spinal Fixation System; MASADA Modular Spinal Fixation SystemAstura Medical20250—
+3K251965Proximity Anterior Cervical Plate System; Segmental Plating System (SPS)Alphatec Spine, Inc.20250—
+3K251719Momentum® Posterior Spinal Fixation SystemUlrich Medical USA, Inc.20250—
+3K243259MASADA Modular Spinal Fixation SystemAstura Medical20250—
+3K243369Cervical Plating SystemLife Spine, Inc.20240—
+3K243015Skyway Anterior Cervical Plate SystemKyocera Medical Technologies, Inc.20242—
+3K243106CarboClear® Hybrid Pedicle Screw SystemCarboFix Orthopedics, Ltd.20240—
+3K233508iFuse Bedrock Granite® Implant SystemSI-BONE, Inc.20245—
+3K232311LnK Spinal Fixation System /OpenLoc-L Spinal Fixation System, AccelFix Spinal Fixation…L&K BIOMED Co., Ltd.20231—
+3K231799INERTIA® CONNEXX™ Modular Pedicle Screw SystemNexxt Spine, LLC20230—
+3K230424Omnia Medical Coupler-A™ Anterior Lumbar Plate System; Omnia Medical Coupler-L™ Lateral…Omnia Medical, LLC20230—
+3K223321Omnia Medical Coupler-C Anterior Cervical PlateOmnia Medical, LLC20230—
+3K221776NextGen Pedicle Screw SystemCorelink, LLC20222—
+3K213935PISCES-SA Standalone ALIF Interbody SystemOsseus Fusion Systems202212—
+3K213901Cyclops™ Anterior Cervical Plate SystemDegen Medical20220—
+3K202657Javelin Tailor's Bunion Fixation SystemNvision Biomedical Technologies, Inc.20201—
+3K202064Admiral ACP SystemSeaSpine Orthopedics Corporation202014—
+3K201029Sapphire® Spinal System, Sapphire X Anterior Cervical Plate Spinal SystemSpinal Elements, Inc.20201—
+3K200995Insignia™ Anterior Cervical Plate SystemAlphatec Spine, Inc.2020729
+3K191786Cyclops™ Anterior Cervical Plate SystemDegen Medical, Inc.20191—
+3K183409Athena II Cervical Plate SystemMedyssey USA, Inc.20191—
+3K183060CervAlign™ Anterior Cervical Plate SystemPioneer Surgical Technology, Inc. (Dba Rti Surgical, Inc.)201921
+3K182473PYRENEES Cervical Plate System, BLUE RIDGE Cervical Plate System, OZARK Cervical Plate…K2m, Inc.20184—
+3K182239OLYMPIC Posterior Spinal Fixation SystemAstura Medical, LLC20182—
+3K182240PASS LP Spinal SystemMedicrea International SA20182—
+3K181549Curiteva Midline Anterior Cervical Plate System (or Curiteva Anterior Cervical Plate…Curiteva, LLC20180—
+3K181562Curiteva Anterior Cervical Plate SystemCuriteva, LLC20180—
+3K180022Athena Cervical Plate SystemMedyssey USA, Inc.20182—
+3K181244Zavation Cervical Plate SystemZavation Medical Products, LLC20187—
+3K180537Zavation Buttress Plate SystemZavation Medical Products, LLC20180—
+3K173306EZ PlateZavation Medical Products, LLC20180—
+3K173115COALITION® and COALITION® TPS, COALITION MIS® and COALITION MIS® TPS, COALITION AGX® and…Globus Medical, Inc.201783—
+3K173091Boundary Anterior Lumbar Buttress PlateNvision Biomedical Technologies, LLC20170—
+3K163366Shanghai Sanyou CARMEN Cervical Fusion SystemShanghai Sanyou Medical Co, Ltd.20170—
+3K172104Ozark (tm) Cervical Plate SystemK2m, Inc.20175—
+3K171881JAZZ Passer BandImplanet, S.A.20170—
+3K163104Terrace™ Anterior Cervical Plate SystemCorelink, LLC201718—
+3K170730JAZZ System, including JAZZ BandImplanet, S.A.20175—
+3K170961NuVasive CoRoent Small Interlock II SystemNu Vasive, Incorporated201718—
+3K163061Altus Spine Cervical Plate SystemAltus Partners, LLC20171—
+3K152193Renovis Anterior Cervical Plate SystemRenovis Surgical Technologies, Inc.20154—
+3K150666uNion Cervical Plate SystemUlrich Medical USA201531
+3K130427Pioneer Aspect Anterior Cervical Plate SystemPioneer Surgical Technology, Inc.20135—
+3K130202Iris Anterior Cervical PlateLife Spine, Inc.201321—
+3K130030Zavation Cervical Plate SystemZavation, LLC201315—
+3K122216Reliance Anterior Cervical Plate SystemReliance Medical Systems, LLC20123—
+3K111528Pioneer Aspect Anterior Cervical Plate Model 24-SeriesPioneer Surgical Technology, Inc.201111—
+3K091396Cardo Medical Anterior Cervical Plate SystemCardo Medical Corp.20092—
+3K072703Pioneer Slimfuse Anterior Cervical Plating SystemPioneer Surgical Technology200819—
+4K262067iFuse Granite Onyx™ Implant SystemSI-BONE, Inc.20260—
+4K260385aprevo® anterior and lateral lumbar interbody system; aprevo® posterior and…Carlsmed, Inc.20260—
+4K261130AccelFix Spinal Fixation SystemL&K BIOMED Co., Ltd.20260—
+4K260570corra™ cervical plating systemCarlsmed, Inc.20261—
+4K254274ARx® SAI Implant SystemLife Spine, Inc.20260—
+4K260291Vortex5 Tailor's Bunion Correction SystemNvision Biomedical Technologies, Inc.20260—
+4K253876HEDRON™ Cervical Spacers (HEDRON C-MIS™ Spacer)Globus Medical, Inc.20251—
+4K252322SIros-X SystemGenesys Spine20250—
+4K253094iFuse Bedrock Granite Implant SystemSI-BONE, Inc.20250—
+4K250845Curiteva Porous PEEK Standalone ALIF SystemCuriteva, Inc.20251—
+4K250486Skyway Anterior Cervical Plate SystemKyocera Medical Technologies Inc. (KMTI)20251—
+4K242361OZARK Cervical Plate System; PYRENEES® Cervical Plate System; EVEREST® Spinal System…Stryker Spine20241—
+4K240326Solar™ Lumbar Interbody Fusion SystemDegen Medical, Inc.20244—
+4K241464ARx® SAI Implant SystemLife Spine, Inc.20241—
+4K240515uNion® MAX Cervical Plate SystemUlrich Medical USA, Inc.20240—
+4K233640Segmental Plating System (SPS);IdentiTi SPS Interbody System;IdentiTi NanoTec SPS…Alphatec Spine, Inc.20245—
+4K231494CoreLink Robotic Navigation InstrumentsCorelink, LLC20230—
+4K232605Sacrix® Sacroiliac Joint Fusion Device System, Inspan® ScrewLES Fusion System, Invue®…Lesspine Innovations20230—
+4K231766Skyway Anterior Cervical Plate SystemKyocera Medical Technologies Inc. (KMTI)20233—
+4K231593Sapphire X3 Anterior Cervical Plate SystemSpinal Elements, Inc.20230—
+4K231735NuVasive CoRoent Small Interbody System; NuVasive CoRoent Small Contoured Interbody…Nu Vasive, Incorporated20239—
+4K231199Solar Lumbar Interbody Fusion SystemDegen Medical20235—
+4K222097OLYMPIC Deformity Band SystemAstura Medical20233—
+4K230880CoreLink Navigation InstrumentsCorelink, LLC20230—
+4K223837SPIRA®-C Integrated Fixation SystemCamber Spine Technologies20230—
+4K230301Athena III Cervical Plate SystemMedyssey USA, Inc.20230—
+4K221053Magnes-C Anterior Cervical Plate SystemFellowship of Orthopaedic Researchers, Inc.20230—
+4K223413Pisces™-SA STANDALONE ALIF Interbody SystemOsseus Fusion Systems20233—
+4K221049Zavation VariSync Plate System and VariSync Spacer SystemZavation Medical Products, LLC20226—
+4K221572VyPlate Anterior Cervical Plate SystemVy Spine, LLC20221—
+4K211417F3D-C2 Cervical Stand-Alone SystemCorelink, LLC20223—
+4K213443Insignia™ Anterior Cervical Plate SystemAlphatec Spine, Inc.20216—
+4K212139Admiral ACP SystemSeaSpine Orthopedics Corporation20216—
+4K211903Shoreline Threaded TruProfile® PlateSeaSpine Orthopedics Corporation20217—
+4K210382Blustone Synergy Diamond SA Cervical SystemBlustone Synergy, LLC20210—
+4K211408CervAlign® Anterior Cervical Plate SystemPioneer Surgical Technology, Inc.20211—
+4K203076Mecta-C Stand Alone ExtensionMedacta International S.A.20200—
+4K202065DOLOMITE Anterior Cervical Stabilization SystemAstura Medical, LLC20203—
+4K201073Seaspine WaveForm C Interbody SystemSeaSpine Orthopedics Corporation202017—
+4K202227Artus™ cervical plate systemUlrich GmbH & Co. KG20200—
+4K200927Transept Cervical Plate SystemNeurostructures, Inc.20200—
+4K200087F3D Cervical Stand-Alone Interbody Fusion SystemCorelink, LLC202025—
+4K193494Origin™ Anterior Cervical Plate SystemOrthopaedic & Spine Development20200—
+4K200170SpineNet SSP SystemSpinenet, LLC20200—
+4K191477AEON-C Stand Alone SystemHuvexel Co., Ltd.201910—
+4K191243HEDRON Cervical SpacersGlobus Medical, Inc.201936—
+4K190885Elevation Spine Saber-C SystemElevation Spine201925—
+4K190016Lateral Plate SystemCorelink, LLC201915—
+4K183084Fuji Cervical Plate SystemAltus Partners, LLC20190—
+4K190376PASS LP Spinal SystemMedicrea International SA201915
+4K180909REVEL SpacersGlobus Medical, Inc.201837—