510(k) Report

Devices descending from K990965

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

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+5K230614Cortium™Ulrich Medical USA20230—
+5K223350Remi Robotic Navigation SystemFusion Robotics, LLC20230—
+5K220862E-GPS Navigated InstrumentsPrecision Spine, Inc.20227—
+5K220810Infinity™ OCT System and PASS OCT Spinal SystemMedicrea International20220—
+5K211616ExcelsiusHubGlobus Medical, Inc.20219Class I
+5K202836GX Navigation Instrument SystemLife Spine, Inc.20211—
+5K211993Z-LINKPC SystemZavation Medical Products, LLC20210—
+5K210963ENNOVATE Spinal SystemAesculap Implant Systems, LLC20210—
+5K201569CUVIS-spineCurexo, Inc.20212—
+5K210449Infinity™ OCT System, PASS OCT® Spinal SystemMedtronic20213—
+5K202184Practical Navigation Surgical Guidance System (PNSGS)Practical Navigation, LLC20215—
+5K203153CREO Stabilization System, Navigation Instruments, ExcelsiusGPSGlobus Medical, Inc.20211—
+5K200793LnK Posterior Cervical Fixation System and CastleLoc-S Posterior Cervical Fixation SystemL&K BIOMED Co., Ltd.202011—
+5K200047ExcelsiusGPS Cranial 1.0 ModuleGlobus Medical, Inc.202053
+5K200863Tiger® Occipital-Cervical-Thoracic Spinal Fixation SystemCorelink, LLC20200—
+5K200070ARx Spinal SystemLife Spine, Inc.20209—
+5K193211Nano FortiFix® SystemNanovis Spine, LLC20201—
+5K200267LOSPA® IS™ Spinal Fixation SystemCorentec Co., Ltd.20201—
+5K193465CorticaLINK Spinal Fusion PlatformSpine Smith Holdings, LLC20200—
+5K193219G Surgical Marksman SystemG Surgical, LLC20191—
+5K191932Momentum™ Posterior Spinal Fixation SystemUlrich Medical USA20192—
+5K191212CrossOver Cross Connectors, DePuy PULSE Thoracolumbar Screw System, EXPEDIUM Fenestrated…Medos International SARL20190—
+5K191575ARx Spinal SystemLife Spine, Inc.201910—
+5K191100ExcelsiusGPS Spine 1.1 Interbody ModuleGlobus Medical, Inc.201942—
+5K191185Solanas® Posterior OCT Fixation SystemAlphatec Spine20194—
+5K183639Mariner Outrigger Revision SystemSeaSpine Orthopedics Corporation20198—
+5K183430Modular Spinal Fixation SystemLife Spine, Inc.20192—
+5K183119SI-LOK® Sacroiliac Joint Fixation System, Navigation Instruments, ExcelsiusGPS®…Globus Medical, Inc.20192—
+5K182000AQrate Robotic Assistance SystemGlobus Medical, Inc.20191—
+5K183080Mega Plus Spine SystemBk Meditech, Co., Ltd.20182—
+5K182239OLYMPIC Posterior Spinal Fixation SystemAstura Medical, LLC20182—
+5K182240PASS LP Spinal SystemMedicrea International SA20182—
+5K180690Navigation InstrumentsGlobus Medical, Inc.20189—
+5K172495Reform® POCT SystemPrecision Spine, Inc.20181—
+5K173508Everest Spinal SystemK2m20189—
+5K173484CorticaLINK Spinal Fusion PlatformLinkspine, Inc.20170—
+5K172194Connector SystemOrthofix, Inc.2017162
+5K170861PremierShandong Weigao Orthopaedic Device Co., Ltd.20170—
+5K170163Erisma® LP Spinal Fixation SystemClariance, Sas20172—
+5K162134ENNOVATE Spinal SystemAesculap Implant Systems, LLC20162—
+5K161498Streamline OCT Occipito-Cervico-Thoracic SystemPioneer Surgical Technology, Inc. (Dba Rti Surgical, Inc.)20161—
+5K153453Inertia Pedicle Screw and Deformity Correxxion SystemNexxt Spine, LLC201617—
+5K151770Libra Pedicle Screw SystemSpinal Balance, Inc.20151—
+5K151974Polaris Spinal SystemBiomet Spine201516—
+5K150896Vitality Spinal Fixation SystemZimmer Spine, Inc.2015193
+5K151422Reform Pedicle Screw SystemPrecision Spine, Inc.201519—
+5K143278LnK Posterior Cervical Fixation SystemL&K BIOMED Co., Ltd.201513—
+5K142835Iliad Pedicle Screw System and Zenius Pedicle Screw SystemMedyssey USA, Inc.20155—
+5K150283Republic Spine Dark Star Spinal SystemRepublic Spine, LLC20154—
+5K142741OASYS SystemStryker Corporation201537—
+5K143248Reform Pedicle Screw SystemPrecision Spine, Inc.201430—
+5K142185Expedium Verse Spine SystemDepuy Spine, Inc.201420—
+5K141291Vertiform Posterior Fixation SystemNext Orthosurgical20142—
+5K132049Thunderbolt and Lancer Pedicle Screw SystemsChoicespine201482—
+5K140529Everest Spinal SystemK2m, LLC201431—
+5K140123Polaris Spinal System -Translation ScrewEbi, LLC2014221
+5K140645Gibralt Rod-to-Rod Cross ConnectorsExactech Sarasota20141—
+5K133944Range, Spinal System, Everest Spinal SystemK2m, Inc.201433—
+5K132757Everest Spinal SystemK2m, Inc.201341—
+5K132361Everest Spinal SystemK2m, Inc.201334—
+5K132644Lospa IS Pedicle Screw (Monoaxial & Polyaxial), Lospa IS Rod- Straight (Standard), Lospa…Corentec Co., Ltd.20130—
+5K131250Tiger Spine SystemCorelink, LLC201340—
+5K131615Polaris Spinal SystemBiomet Spine (Aka Ebi, LLC)201370—
+5K130887S4C Navigation InstrumentsAesculap Implant System, Inc.201313—
+5K131030Range Spinal SystemK2m, Inc.201334—
+5K130330Range Spinal SystemK2m, Inc.201336—
+5K130291S4 Spinal SystemAesculap Implant System, Inc.201344—
+5K123352S4 Spinal SystemAesculap Implant Systems, Inc.201251—
+5K122226Revere Stabilization SystemGlobus Medical, Inc.2012225—
+5K121016Range Spinal System (Mesa and Denali)K2m, Inc.201238—
+5K121130Polaris Spinal System-Ballista Spinal RodsBiomet Spine20121—
+5K120899Range Spinal System, Unit RodK2m, Inc.201235—
+5K120928Synthes Matrix SystemSynthes Spine20120—
+5K110896Reliance Spinal Screw SystemReliance Medical Systems, LLC20125—
+5K110551Expedium Spine SystemJohnson & Johnson20111—
+5K111571Viper SystemsJohnson & Johnson2011203—
+5K101993Viper System, Expedium SystemDepuy Spine, Inc.20101628
+5K101112Reliance Spinal Screw SystemReliance Medical Systems20107—
+5K092473Expedium Spine SystemDepuy Spine, Inc.2009263—
+5K081978Reliance Spinal Screw SystemReliance Medical Systems, LLC20098—
+5K081898Expedium Spine SystemDepuy Spine, Inc.200859—
+5K073430Valeo Pedicle Screw Spinal SystemAmedica Corp.200824—
+6K261284Invictus® Small Stature Spinal Fixation System; Invictus® 2.0 Spinal Fixation SystemAlphatec Spine, Inc.20260—
+6K260369Dynamis Robotic Surgical SystemLEM Surgical AG20260—
+6K261665CORUS™ Navigation System-GNProvidence Medical Technology, Inc.20260—
+6K260571SIMPACT Sacroiliac Joint Fixation System GX Navigation InstrumentsLife Spine, Inc.20260—
+6K253739SCRIPT™ Rods, CREO™ Stabilization System, REVERE® Stabilization System, REVERE® 4.5…Globus Medical, Inc.20260—
+6K253545Vulcan Spinal SystemK2m, Inc.20260—
+6K250599ExcelsiusGPS™ InstrumentsGlobus Medical, Inc.20250—
+6K252346OLYMPIC Posterior Spinal Fixation System; MASADA Modular Spinal Fixation SystemAstura Medical20250—
+6K252437JAZZ Spinal SystemImplanet20250—
+6K251060CORUS™ Navigation System-GXProvidence Medical Technology, Inc.20250—
+6K251719Momentum® Posterior Spinal Fixation SystemUlrich Medical USA, Inc.20250—
+6K243259MASADA Modular Spinal Fixation SystemAstura Medical20250—
+6K243106CarboClear® Hybrid Pedicle Screw SystemCarboFix Orthopedics, Ltd.20240—
+6K230325GREENS BRAND Posterior, Non-cervical Pedicle Screw Spinal SystemGreens Surgicals Pvt., Ltd.20240—
+6K242069Eminent Spine Scoliosis Deformity Pedicle Screw SystemEminent Spine20240—
+6K240180Orthopeasia Spinal Fixation SystemOrthopeasia Co., Ltd.20240—
+6K233793CarboClear® X Pedicle Screw SystemCarboFix Orthopedics, Ltd.20241—
+6K233256Robotic Integration InstrumentsDePuy Synthes20240—