510(k) Report

Devices descending from K030377

391 later devices reach Modification to Synthes Cervifix System through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+5K230245LnK Spinal Fixation System/OpenLoc-L Spinal Fixation System; AccelFix Spinal Fixation…L&K BIOMED Co., Ltd.20233—
+5K221776NextGen Pedicle Screw SystemCorelink, LLC20222—
+5K202836GX Navigation Instrument SystemLife Spine, Inc.20211—
+5K212066Adena-Zina SystemShanghai Sanyou Medical Co, Ltd.20213—
+5K210427M.U.S.T. Midline Cortical (MC) Screw SystemMedacta International S.A.20210—
+5K203482M.U.S.T. Pedicle Screw Extension and Long Tab ImplantsMedacta International S.A.20215—
+5K203153CREO Stabilization System, Navigation Instruments, ExcelsiusGPSGlobus Medical, Inc.20211—
+5K200070ARx Spinal SystemLife Spine, Inc.20209—
+5K191655MEGAFIX® Pedicle Screw Spinal SystemSeohancare Co., Ltd.20200—
+5K193365M.U.S.T. Pedicle Screw SystemMedacta International S.A.20207—
+5K191932Momentum™ Posterior Spinal Fixation SystemUlrich Medical USA20192—
+5K191575ARx Spinal SystemLife Spine, Inc.201910—
+5K191835CREO Stabilization System, Navigation Instruments, ExcelsiusGPS InstrumentsGlobus Medical, Inc.20192—
+5K190376PASS LP Spinal SystemMedicrea International SA201915
+5K190361Zavation Spinal SystemZavation Medical Products, LLC20190—
+5K183430Modular Spinal Fixation SystemLife Spine, Inc.20192—
+5K181978Zenius™, Iliad™ and Kora™ Spinal Fixation SystemsMedyssey USA, Inc.20180—
+5K181068CREO® Stabilization System, REVERE® Stabilization SystemGlobus Medical, Inc.20182—
+5K180210CREO® Stabilization SystemGlobus Medical, Inc.201888—
+5K171758M.U.S.T. Combined Set ScrewsMedacta International S.A.20177—
+5K171438Palisade™ Pedicular Fixation SystemSpineology, Inc.20171—
+5K171170M.U.S.T. Pedicle Screw System Extension - Straight Connectors and Additional ScrewsMedacta International S.A.201723—
+5K170989Dymaxeon Spine SystemBack 2 Basics Direct, LLC20172—
+5K170964Zenius Spinal SystemMedyssey USA, Inc.20170—
+5K162134ENNOVATE Spinal SystemAesculap Implant Systems, LLC20162—
+5K162061M.U.S.T. Pedicle Screw SystemMedacta International S.A.201615—
+5K161014NuVasive® Reline® SystemNu Vasive, Incorporated201648—
+5K160989NuVasive® Reline® SystemNu Vasive, Incorporated201667—
+5K153664M.U.S.T. Pedicle Screw SystemMedacta International201624—
+5K151974Polaris Spinal SystemBiomet Spine201516—
+5K150896Vitality Spinal Fixation SystemZimmer Spine, Inc.2015193
+5K151422Reform Pedicle Screw SystemPrecision Spine, Inc.201519—
+5K150184Dymaxeon Spine SystemBack 2 Basics Direct, LLC201541
+5K142835Iliad Pedicle Screw System and Zenius Pedicle Screw SystemMedyssey USA, Inc.20155—
+5K150647Polyscrew Pedicle Screw SystemNew Era Orthopedics, LLC201501
+5K143633CREO Stabilization SystemGlobus Medical, Inc.2015158—
+5K141253New Era Orthopaedics Polyscrew Pedicle Screw SystemNew Era Orthopaedics, LLC201511
+5K143248Reform Pedicle Screw SystemPrecision Spine, Inc.201430—
+5K132788Myspine Pedicle Screw Placement GuidesMedacta International201412—
+5K140529Everest Spinal SystemK2m, LLC201431—
+5K133366Orthros Posterior Stabilization SystemCamber Spine20142—
+5K133944Range, Spinal System, Everest Spinal SystemK2m, Inc.201433—
+5K132878M.U.S.T. ExtensionMedacta International201328—
+5K132757Everest Spinal SystemK2m, Inc.201341—
+5K132361Everest Spinal SystemK2m, Inc.201334—
+6K260286Dynamo™ Spinal Cement; Salvo® Spine SystemSpine Wave, Inc.20260—
+6K260571SIMPACT Sacroiliac Joint Fixation System GX Navigation InstrumentsLife Spine, Inc.20260—
+6K254045CarboClear® Posterior Cervical Screw System; CarboClear® Hybrid Posterior Cervical Screw…CarboFix Orthopedics, Ltd.20260—
+6K253545Vulcan Spinal SystemK2m, Inc.20260—
+6K252885OLYMPIC Posterior Spinal Fixation System; MASADA Modular Spinal Fixation SystemAstura Medical20260—
+6K252327CMORE® CT System; CMORE® CT System Navigated InstrumentsIcotec AG20251—
+6K252346OLYMPIC Posterior Spinal Fixation System; MASADA Modular Spinal Fixation SystemAstura Medical20250—
+6K251719Momentum® Posterior Spinal Fixation SystemUlrich Medical USA, Inc.20250—
+6K230325GREENS BRAND Posterior, Non-cervical Pedicle Screw Spinal SystemGreens Surgicals Pvt., Ltd.20240—
+6K241276Vector™ Pedicle Screw SystemInnovasis, Inc.202411
+6K240872Erisma® Deformity Spinal System; Erisma® Lp Spinal Fixation SystemClariance20241—
+6K231809Momentum® Posterior Spinal Fixation System with G21 V-STEADY Bone Cement; Momentum® MIS…Ulrich Medical USA20231—
+6K230961Zeus Spinal SystemShanghai Sanyou Medical Co, Ltd.20232—
+6K232311LnK Spinal Fixation System /OpenLoc-L Spinal Fixation System, AccelFix Spinal Fixation…L&K BIOMED Co., Ltd.20231—
+6K222229Advanced LumFix Spinal Fixation SystemCG Bio Co., Ltd.20232—
+6K230880CoreLink Navigation InstrumentsCorelink, LLC20230—
+6K213196MARVEL™ Growing RodsGlobus Medical, Inc.20220—
+6K220341ARx Modular Spinal SystemLife Spine, Inc.20221—
+6K213281PASS LP™ Spinal System, CD Horizon™ Spinal SystemMedicrea International SA20220—
+6K210963ENNOVATE Spinal SystemAesculap Implant Systems, LLC20210—
+6K210549ARx Spinal SystemLife Spine, Inc.20211—
+6K210275Polaris Spinal SystemZimmer Biomet Spine, Inc.20210—
+6K203163ARx Illiac Spinal Screw SystemLife Spine, Inc.20205—
+6K203367LineSider™ Spinal SystemIntegrity Implants, Inc.202054
+6K200937ACURA Stabilization SystemIndius Medical Technologies Pvt., Ltd.20200—
+6K200303Reform Pedicle Screw SystemPrecision Spine202010—
+6K192930Dymaxeon Spine SystemBack 2 Basics Direct, LLC20201—
+6K193472OrthoCircle Spine Pedicle Screw SystemOrthocircle Spine20200—
+6K193396PERLA® TL posterior osteosynthesis systemSpineart202072
+6K192938Invictus™ Spinal Fixation SystemAlphatec Spine, Inc.201969—
+6K192121Black Diamond Pedicle Screw SystemOsseus Fusion Systems201913—
+6K182974NuVasive Reline SystemNu Vasive, Incorporated201911—
+6K182478Whistler Modular Pedicle Screw SystemEvolution Spine, LLC20196—
+6K182954Salvo™ Spine SystemSpine Wave, Inc.20186—
+6K180754C-Zero Pedicle Screw System, Freedom Pedicle Screw SystemSignature Orthopaedics Pty, Ltd.20180—
+6K180498NuVasive Reline Fenestrated Screws, High V+ Bone CementNu Vasive, Incorporated201841—
+6K180980ORTHROS™ Posterior Stabilization System; ORTHROS™ MIS Posterior Stabilization SystemCamber Spine Technologies, LLC20181—
+6K180433Ennovate®Aesculap Implant Systems, LLC201811
+6K173472MySpine Pedicle Screw Placement Guides – MC and Drill Pilot InstrumentsMedacta International S.A.20185—
+6K180198NuVasive® VuePoint® II OCT SystemNu Vasive, Incorporated20184—
+6K173508Everest Spinal SystemK2m20189—
+6K171894NuVasive® Precept™ Spinal SystemNu Vasive, Incorporated20170—
+6K172101ROMEO® 2 Posterior Osteosynthesis SystemSpineart20179—
+6K171651Excelsius GPSGlobus Medical, Inc.2017691
+6K170861PremierShandong Weigao Orthopaedic Device Co., Ltd.20170—
+6K171907Vitality® Spinal Fixation SystemZimmer Biomet Spine, Inc.2017162
+6K171509Iliad® Pedicle Screw System and Zenius® Pedicle Screw SystemMedyssey USA, Inc.20171—
+6K170126NuVasive® Reline® 4.5-5.0 SystemNu Vasive, Incorporated201739—
+6K153273MySpine Pedicle Screw Placement Guides - LPMedacta International S.A.20166—
+6K143222FIREFLY Pedicle Screw Navigation GuideMighty Oak Medical, Inc.20158—
+6K151727Everest Spinal SystemK2m, Inc.201511—
+6K150856Reform Pedicle Screw SystemPrecision Spine, Inc.201526—
+6K142360Everest Spinal SystemK2m, Inc.201522—
+6K143334Range/Denali/Mesa Spinal SystemK2m, Inc.201516—
+6K141873Range/Mesa/Denali Spinal SystemK2m, Inc.201430—