510(k) Report

Devices descending from K990965

672 later devices reach Synthes Cervifix System through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+7K253401SCRIPT™ Implant SystemGlobus Medical, Inc.20260—
+7K253990KHEIRON® Spinal Fixation System, including patient specific K-RODS.M.A.I.O20262—
+7K253876HEDRON™ Cervical Spacers (HEDRON C-MIS™ Spacer)Globus Medical, Inc.20251—
+7K253249TriALTIS™ Spine SystemMedos International SARL20251—
+7K242827A8 INTEGR8™ Porous Pedicle ScrewsAllumin8, Inc.20251—
+7K252737DeGen Medical Latitude-C AM Cervical Interbody Fusion SystemDegen Medical20250—
+7K251131Annex® 2 Adjacent Level SystemSpine Wave, Inc.20250—
+7K250582COLONNADE Posterior Screw Fixation SystemCG Bio Co., Ltd.20250—
+7K242297Reform Pedicle Screw SystemPrecision Spine, Inc.20240—
+7K243281LOCK-IN Spinal Fixation SystemLock-In USA Corp20240—
+7K243635aprevo® anterior lumbar interbody fusion device with interfixationCarlsmed, Inc.20245—
+7K242764MediRod Pedicle Screw SystemCmf Medicon Surgical, Inc.20240—
+7K234035COSINE™ SpacerGlobus Medical, Inc.20240—
+7K241846E3D™-C Interbody SystemEvolution Spine20246—
+7K241464ARx® SAI Implant SystemLife Spine, Inc.20241—
+7K241863Erisma® Lp Spinal Fixation System; Erisma® LP MISClariance20240—
+7K234077SPIRA® Anterior Lumbar SpacersCamber Spine Technologies20240—
+7K240846CarboClear® Hybrid Pedicle Screw System; CarboClear® Hybrid Navigated Instruments…CarboFix Orthopedics, Ltd.20242—
+7K234048M.U.S.T. Pedicle Screw System - ExtensionMedacta International S.A.20241—
+7K233455ARx MIS Spinal Screw SystemLife Spine, Inc.20230—
+7K232719ProMIS Extension Rod SystemPremia Spine, Ltd.20230—
+7K231694MASADA Modular Spinal Fixation SystemAstura Medical20232—
+7K232318VICTORY™ Lumbar Plate SystemGlobus Medical, Inc.20230—
+7K232586Rexious Spinal Fixation System, Statera™ Spinal System, Statera-M™ Spinal SystemK&J Consulting Corp.20230—
+7K231744VyLink™ Spinal Screw SystemVy Spine, LLC20230—
+7K231658VEOS Spinal Fixation SystemSpineway20230—
+7K232413Fusion Robotic Navigation SystemAlphatec Spine, Inc.20232—
+7K231839CastleLoc-P Anterior Cervical Plate System, AccelFix Lumbar Plate SystemL&K BIOMED Co., Ltd.20232—
+7K231841PathLoc SI Joint Fusion SystemL&K BIOMED Co., Ltd.20231—
+7K231844ProMIS™ Fixation SystemPremia Spine, Ltd.20231—
+7K231280CarboClear® X Pedicle Screw System; CarboClear® X Navigated Instruments; CarboClear® X…CarboFix Orthopedics, Ltd.20234—
+7K231199Solar Lumbar Interbody Fusion SystemDegen Medical20235—
+7K223837SPIRA®-C Integrated Fixation SystemCamber Spine Technologies20230—
+7K223521ZESPIN SI Joint Fusion SystemAegis Spine, Inc.20232—
+7K223719Paeon Anterior Cervical Plate System, Elatus Lumbar Plate SystemAegis Spine, Inc.20233—
+7K222473EXPEDIUM® Spine System, EXPEDIUM VERSE® Spine System: ALTALYNE™ Ultra RodsMedos-International Sarl20221—
+7K221776NextGen Pedicle Screw SystemCorelink, LLC20222—
+7K221332OsteoCentric Spine MIS Pedicle Fastener SystemOsteoCentric Technologies20221—
+7K213935PISCES-SA Standalone ALIF Interbody SystemOsseus Fusion Systems202212—
+7K220374EXPEDIUM VERSE® Fenestrated Screw System (Sterile Fenestrated Screws)Medos International SARL20229—
+7K213470PERLA® TL Posterior Osteosynthesis SystemSpineart20222—
+7K213281PASS LP™ Spinal System, CD Horizon™ Spinal SystemMedicrea International SA20220—
+7K212489BonOs Inject Bone Cement; NEO Pedicle Screw SystemNeo Medical SA20215—
+7K211935ORIO-Ti Intervertebral Body Fusion Cage SystemSpinecraft, LLC20210—
+7K203607MOSS VRS Spinal SystemBiedermann Motech GmbH & Co. KG20210—
+7K212185Golden Isles Pedicle Screw SystemIntelivation, LLC20210—
+7K212066Adena-Zina SystemShanghai Sanyou Medical Co, Ltd.20213—
+7K210874Reliance Spinal Screw SystemReliance Medical Systems, LLC20212—
+7K201420Republic Spine Dark Star Spinal SystemRepublic Spine, LLC20212—
+7K203319SYMPHONY™ OCT SystemMedos International SARL20211—
+7K203506PERLA® TL posterior osteosynthesis systemSpineart202132
+7K203222PERLA TL Posterior Osteosynthesis SystemSpineart20204—
+7K200937ACURA Stabilization SystemIndius Medical Technologies Pvt., Ltd.20200—
+7K200596G21 Cement, VADER® Pedicle SystemIcotec AG2020271
+7K201006K2M Navigation InstrumentsK2m, Inc.20200—
+7K201926CarboClear® Pedicle Screw System, CarboClear® II Pedicle Screw SystemCarboFix Orthopedics, Ltd.202010—
+7K201251CarboClear Navigated InstrumentsCarboFix Orthopedics, Ltd.20209—
+7K193423VADER®one Pedicle System MIS and LightMore® Pedicle System 6.0Icotec AG202061
+7K192938Invictus™ Spinal Fixation SystemAlphatec Spine, Inc.201969—
+7K192281AEGIS Anterior Lumbar Plate System, ALC Dynamized Fixation System, Anterior ISOLA Spine…Medos International SARL20190—
+7K192911Brainlab Compatible K2M Navigation InstrumentsK2m, Inc.20199—
+7K190526High V+ Bone Cement, CarboClear® Fenestrated Pedicle ScrewsCarboFix Orthopedics, Ltd.201928—
+7K191726mont blanc & mont blanc MIS Spinal SystemsSpineway SA20190—
+7K191835CREO Stabilization System, Navigation Instruments, ExcelsiusGPS InstrumentsGlobus Medical, Inc.20192—
+7K190545VADER® one Pedicle System MIS and LightMore® Pedicle System 6.0Icotec AG2019291
+7K182478Whistler Modular Pedicle Screw SystemEvolution Spine, LLC20196—
+7K182954Salvo™ Spine SystemSpine Wave, Inc.20186—
+7K182598VersaLink™ Fixation SystemPremia Spine, Ltd.20180—
+7K181821MOSS VRS Spinal SystemBiedermann Motech GmbH & Co. KG20181—
+7K181978Zenius™, Iliad™ and Kora™ Spinal Fixation SystemsMedyssey USA, Inc.20180—
+7K181677Kodiak Spinal Fixation SystemAlphatec Spine, Inc.201870—
+7K181339Altus Spine Pedicle Screw SystemAltus Partners, LLC20186—
+7K181139OLYMPIC Posterior Spinal Fixation SystemAstura Medical, LLC20188—
+7K181068CREO® Stabilization System, REVERE® Stabilization SystemGlobus Medical, Inc.20182—
+7K181281Altus Spine Pedicle Screw SystemAltus Partners, LLC20181—
+7K173814DeGen Medical E3 MIS Pedicle Screw SystemDegen Medical20180—
+7K171421VERTICALE® Posterior Spinal Fixation System/VERTICALE® SystemSilony Medical GmbH20186—
+7K173130Reform® Midline Cortical Screw SystemPrecision Spine, Inc.201721—
+7K172275Vitality® Spinal Fixation System, Vitality®+ Power Instrument SystemZimmer Biomet Spine, Inc.20170—
+7K171832Range/Denali/Mesa Spinal SystemK2m, Inc.201713—
+7K171582NEO Pedicle Screw System™Neo Medical SA20170—
+7K171321K2M Navigation InstrumentsK2m201711
+7K172107Threshold™ V2 Pedicular Fixation System, Threshold™ Pedicular Fixation System, Fortress™…Spineology, Inc.20170—
+7K161225Paonan Armstrong Posterior Spinal Fixation SystemPaonan Biotech Co., Ltd.20172—
+7K171438Palisade™ Pedicular Fixation SystemSpineology, Inc.20171—
+7K170061ProMIS™ Fixation SystemPremia Spine, Ltd.20170—
+7K161387Mont Blanc and Mont Blanc MIS Spinal SystemsSpineway SA20163—
+7K161028K2M Growing Spine SystemK2m, Inc.20163—
+7K161369EVEREST Spinal SystemK2m, Incorporated20169—
+7K160208NILE Alternative Fixation Spinal SystemK2m, Inc.20165—
+7K153442CD HORIZON Spinal System, Medtronic Navigated Manual Reusable Instruments for Use with…Medtronic Sofamor Danek USA, Inc.201684—
+7K151216Everest Spinal SystemK2m, Inc.201511—
+7K151755OASYS (r) SystemStryker Corporation201533—
+7K150417Astra Spine SystemSpinecraft, LLC201521—
+7K150647Polyscrew Pedicle Screw SystemNew Era Orthopedics, LLC201501
+7K150325Range/Denali/Mesa Spinal SystemK2m, Inc.201512—
+7K143200MIS Z-Pedicle Screw SystemZ-Medical GmbH & Co. KG201514—
+7K143633CREO Stabilization SystemGlobus Medical, Inc.2015158—
+7K141253New Era Orthopaedics Polyscrew Pedicle Screw SystemNew Era Orthopaedics, LLC201511
+7K133402K2M Modular HooksK2m, Inc.20140—