510(k) Report

Devices descending from K945700

692 later devices reach Synthes (Usa) Anterior Cervical Vertebrae Plate System through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+5K170251Threshold™ Pedicular Fixation SystemSpineology, Inc.20171—
+5K170268Fortress™ Pedicular Fixation SystemSpineology, Inc.20171—
+5K163604SeaSpine® Daytona® Small Stature Spinal SystemSeaSpine Orthopedics Corporation201712—
+5K163602Kepler I Cervical Plate SystemOrbbo Surgical, LLC20170—
+5K161442NuVasive® CoRoent® Small Interlock™ SystemNu Vasive, Incorporated201694—
+5K161014NuVasive® Reline® SystemNu Vasive, Incorporated201648—
+5K160989NuVasive® Reline® SystemNu Vasive, Incorporated201667—
+5K153404Zavation Spinal SystemZavation, LLC20161—
+5K151704Diplomat® Spinal SystemSignus Medizintechnik GmbH20164—
+5K152282Cam Lock Plating SystemLife Spine, Inc.20151—
+5K152148Fortress Pedicular Fixation SystemSpineology, Inc.20158—
+5K151422Reform Pedicle Screw SystemPrecision Spine, Inc.201519—
+5K151216Everest Spinal SystemK2m, Inc.201511—
+5K151196Nautilus Spinal SystemLife Spine, Inc.201512—
+5K143028Azure Anterior Cervical Plate SystemOrthofix, Inc.20150—
+5K143248Reform Pedicle Screw SystemPrecision Spine, Inc.201430—
+5K141850Flospine Pedicle Screw SystemFlospine20140—
+5K141804Polaris Spinal System - HA CoatedBiomet Spine, LLC201421—
+5K141005Z-Link CervicalZavation, LLC20144—
+5K141376Inertia Pedicle Screw System, Honour Spacer System, Facet Fixx, Struxxure Anterior…Nexxt Spine, LLC2014106—
+5K140123Polaris Spinal System -Translation ScrewEbi, LLC2014221
+5K133746Polaris Spinal SystemBiomet Spine (Aka Ebi, LLC)2014671
+5K133350Revere Stabilization SystemGlobus Medical, Inc.201493—
+5K132403Annextm Adjacent Level SystemSpine Wave, Inc.20142—
+5K131429Reliance Cervical Ibf SystemReliance Medical Systems, LLC201324—
+5K123783Ellipse Occipito-Cerico-Thoracic Spinal System and Capitol ImplantsGlobus Medical, Inc.201397—
+5K121786Dymaxeon Spine SystemB2b Spine Pty, Ltd.20125—
+6K262067iFuse Granite Onyx™ Implant SystemSI-BONE, Inc.20260—
+6K262828KHEIRON® Spinal Fixation System, including patient specific K-RODS.M.A.I.O20260—
+6K254148VERTICALE GPS InstrumentsSilony Medical GmbH20260—
+6K253990KHEIRON® Spinal Fixation System, including patient specific K-RODS.M.A.I.O20262—
+6K253249TriALTIS™ Spine SystemMedos International SARL20251—
+6K252737DeGen Medical Latitude-C AM Cervical Interbody Fusion SystemDegen Medical20250—
+6K251780iGPS Navigation InstrumentsSI-BONE, Inc.20250—
+6K251575IdentiTi™ II ALIF Standalone Interbody System; Transcend™ ALIF Standalone Interbody SystemAlphatec Spine20250—
+6K252437JAZZ Spinal SystemImplanet20250—
+6K252113PRADO™ Lumbar Interbody Fusion SystemBethesda Medical Devices20250—
+6K251073Innovasis Navigation Instruments (Vector G-E Navigation Instruments and the Excella G-E…Innovasis, Inc.202501
+6K241525ExcelsiusXR™Globus Medical, Inc.20250—
+6K251080IdentiTi II Cervical Interbody SystemAlphatec Spine, Inc.20250—
+6K251131Annex® 2 Adjacent Level SystemSpine Wave, Inc.20250—
+6K243326Dynamis Robotic Surgical SystemLEM Surgical AG20251—
+6K243514Salvo® Robotic Navigation InstrumentsSpine Wave, Inc.20250—
+6K243814NuVasive Pulse SystemGlobus Medical, Inc.20250—
+6K243671ExcelsiusGPS® InstrumentsGlobus Medical, Inc.20240—
+6K243369Cervical Plating SystemLife Spine, Inc.20240—
+6K240160EGPS Navigated InstrumentsAstura Medical20240—
+6K240721ExcelsiusFlex™Globus Medical, Inc.20240—
+6K240951Invictus Robotic Navigation InstrumentsAlphatec Spine20242—
+6K241276Vector™ Pedicle Screw SystemInnovasis, Inc.202411
+6K240392JAZZ Spinal SystemImplanet20241—
+6K240568DuraPro™ Oscillating SystemGlobus Medical, Inc.20240—
+6K240872Erisma® Deformity Spinal System; Erisma® Lp Spinal Fixation SystemClariance20241—
+6K232256Alcantara Thoracolumbar Plate SystemCamber Spine Technologies, LLC20240—
+6K231850QUARTEX® Occipito-Cervico-Thoracic Spinal System ExcelsiusGPS® InstrumentsGlobus Medical, Inc.20242—
+6K240201PathLoc SI Joint Fusion SystemL&K BIOMED Co., Ltd.20240—
+6K234048M.U.S.T. Pedicle Screw System - ExtensionMedacta International S.A.20241—
+6K233638VERZA™ High Speed DrillsGlobus Medical, Inc.20241—
+6K233300POWEReam 1/4 DriveStryker Instruments20231—
+6K231743F3D Lateral Lumbar Interbody System, CL5 Lateral Lumbar Interbody System, and Oro…Corelink, LLC20233—
+6K232719ProMIS Extension Rod SystemPremia Spine, Ltd.20230—
+6K232318VICTORY™ Lumbar Plate SystemGlobus Medical, Inc.20230—
+6K231494CoreLink Robotic Navigation InstrumentsCorelink, LLC20230—
+6K231069PERLA® TL Posterior Thoraco-lumbar Fixation SystemSpineart SA20231—
+6K232586Rexious Spinal Fixation System, Statera™ Spinal System, Statera-M™ Spinal SystemK&J Consulting Corp.20230—
+6K232341CarboClear® Pedicle Screw SystemCarboFix Orthopedics, Ltd.20234—
+6K232044Invictus Robotic Navigation InstrumentsAlphatec Spine, Inc.20233—
+6K232311LnK Spinal Fixation System /OpenLoc-L Spinal Fixation System, AccelFix Spinal Fixation…L&K BIOMED Co., Ltd.20231—
+6K231799INERTIA® CONNEXX™ Modular Pedicle Screw SystemNexxt Spine, LLC20230—
+6K223558CUVIS-spineCurexo, Inc.20230—
+6K223350Remi Robotic Navigation SystemFusion Robotics, LLC20230—
+6K222473EXPEDIUM® Spine System, EXPEDIUM VERSE® Spine System: ALTALYNE™ Ultra RodsMedos-International Sarl20221—
+6K221403Cortera Spinal Fixation SystemSurgalign Spine Technologies202232
+6K221905INERTIA CONNEXX Modular Pedicle Screw SystemNexxt Spine, LLC20221—
+6K220862E-GPS Navigated InstrumentsPrecision Spine, Inc.20227—
+6K213935PISCES-SA Standalone ALIF Interbody SystemOsseus Fusion Systems202212—
+6K220038Camber Spine Navigation SystemCamber Spine Technologies20220—
+6K220025ARx® Spinal SystemLife Spine, Inc.20220—
+6K202266Reliance Cervical IBF SystemReliance Medical Systems, LLC20223—
+6K220374EXPEDIUM VERSE® Fenestrated Screw System (Sterile Fenestrated Screws)Medos International SARL20229—
+6K213470PERLA® TL Posterior Osteosynthesis SystemSpineart20222—
+6K213115CHENA-C Spacer SystemKahtnu Surgical, Inc.20210—
+6K211616ExcelsiusHubGlobus Medical, Inc.20219Class I
+6K202836GX Navigation Instrument SystemLife Spine, Inc.20211—
+6K211205Prase-C Anterior Cervical Plate SystemGbs Commonwealth Co., Ltd.20210—
+6K201569CUVIS-spineCurexo, Inc.20212—
+6K210275Polaris Spinal SystemZimmer Biomet Spine, Inc.20210—
+6K203065Lumbar Spine Truss System Plating Solution (LSTS-PS)4Web, Inc.20219—
+6K202184Practical Navigation Surgical Guidance System (PNSGS)Practical Navigation, LLC20215—
+6K200922Altus Spine HA Pedicle Screw SystemAltus Partners, LLC20213—
+6K203125Invictus™ OCT Spinal Fixation SystemAlphatec Spine, Inc.20200—
+6K203222PERLA TL Posterior Osteosynthesis SystemSpineart20204—
+6K203056Invictus™ Spinal Fixation SystemAlphatec Spine, Inc.202061—
+6K202327Invictus™ OsseoScrew® SystemAlphatec Spine, Inc.20200—
+6K202192STRUXXURE®-L and STRUXXURE®-A Plate SystemNexxt Spine, LLC20200—
+6K200047ExcelsiusGPS Cranial 1.0 ModuleGlobus Medical, Inc.202053
+6K200936Invictus™ CT Spinal Fixation SystemAlphatec Spine, Inc.20203—
+6K200303Reform Pedicle Screw SystemPrecision Spine202010—
+6K200070ARx Spinal SystemLife Spine, Inc.20209—
+6K200381Daytona® Small Stature Spinal SystemSeaSpine Orthopedics Corporation20202—