510(k) Report

Devices descending from K002733

671 later devices reach Summit Occipito-Cervico-Thoracic (Oct) Spinal System through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+4K201569CUVIS-spineCurexo, Inc.20212—
+4K210449Infinity™ OCT System, PASS OCT® Spinal SystemMedtronic20213—
+4K202184Practical Navigation Surgical Guidance System (PNSGS)Practical Navigation, LLC20215—
+4K203153CREO Stabilization System, Navigation Instruments, ExcelsiusGPSGlobus Medical, Inc.20211—
+4K200793LnK Posterior Cervical Fixation System and CastleLoc-S Posterior Cervical Fixation SystemL&K BIOMED Co., Ltd.202011—
+4K200047ExcelsiusGPS Cranial 1.0 ModuleGlobus Medical, Inc.202053
+4K200863Tiger® Occipital-Cervical-Thoracic Spinal Fixation SystemCorelink, LLC20200—
+4K200896Solstice CCILife Spine, Inc.20200—
+4K193211Nano FortiFix® SystemNanovis Spine, LLC20201—
+4K200267LOSPA® IS™ Spinal Fixation SystemCorentec Co., Ltd.20201—
+4K193465CorticaLINK Spinal Fusion PlatformSpine Smith Holdings, LLC20200—
+4K193219G Surgical Marksman SystemG Surgical, LLC20191—
+4K191932Momentum™ Posterior Spinal Fixation SystemUlrich Medical USA20192—
+4K191212CrossOver Cross Connectors, DePuy PULSE Thoracolumbar Screw System, EXPEDIUM Fenestrated…Medos International SARL20190—
+4K191100ExcelsiusGPS Spine 1.1 Interbody ModuleGlobus Medical, Inc.201942—
+4K191185Solanas® Posterior OCT Fixation SystemAlphatec Spine20194—
+4K183639Mariner Outrigger Revision SystemSeaSpine Orthopedics Corporation20198—
+4K183119SI-LOK® Sacroiliac Joint Fixation System, Navigation Instruments, ExcelsiusGPS®…Globus Medical, Inc.20192—
+4K182000AQrate Robotic Assistance SystemGlobus Medical, Inc.20191—
+4K183080Mega Plus Spine SystemBk Meditech, Co., Ltd.20182—
+4K182239OLYMPIC Posterior Spinal Fixation SystemAstura Medical, LLC20182—
+4K182240PASS LP Spinal SystemMedicrea International SA20182—
+4K180690Navigation InstrumentsGlobus Medical, Inc.20189—
+4K172495Reform® POCT SystemPrecision Spine, Inc.20181—
+4K173508Everest Spinal SystemK2m20189—
+4K173484CorticaLINK Spinal Fusion PlatformLinkspine, Inc.20170—
+4K172194Connector SystemOrthofix, Inc.2017162
+4K170861PremierShandong Weigao Orthopaedic Device Co., Ltd.20170—
+4K162266The Cranial Fusion SystemLife Spine, Inc.20171—
+4K170163Erisma® LP Spinal Fixation SystemClariance, Sas20172—
+4K162134ENNOVATE Spinal SystemAesculap Implant Systems, LLC20162—
+4K161498Streamline OCT Occipito-Cervico-Thoracic SystemPioneer Surgical Technology, Inc. (Dba Rti Surgical, Inc.)20161—
+4K153453Inertia Pedicle Screw and Deformity Correxxion SystemNexxt Spine, LLC201617—
+4K151770Libra Pedicle Screw SystemSpinal Balance, Inc.20151—
+4K151974Polaris Spinal SystemBiomet Spine201516—
+4K150896Vitality Spinal Fixation SystemZimmer Spine, Inc.2015193
+4K151422Reform Pedicle Screw SystemPrecision Spine, Inc.201519—
+4K143278LnK Posterior Cervical Fixation SystemL&K BIOMED Co., Ltd.201513—
+4K151196Nautilus Spinal SystemLife Spine, Inc.201512—
+4K142835Iliad Pedicle Screw System and Zenius Pedicle Screw SystemMedyssey USA, Inc.20155—
+4K150283Republic Spine Dark Star Spinal SystemRepublic Spine, LLC20154—
+4K150229SOLSTICE OCT SystemLife Spine, Inc.20150—
+4K142741OASYS SystemStryker Corporation201537—
+4K143248Reform Pedicle Screw SystemPrecision Spine, Inc.201430—
+4K142185Expedium Verse Spine SystemDepuy Spine, Inc.201420—
+4K141291Vertiform Posterior Fixation SystemNext Orthosurgical20142—
+4K132049Thunderbolt and Lancer Pedicle Screw SystemsChoicespine201482—
+4K140529Everest Spinal SystemK2m, LLC201431—
+4K140123Polaris Spinal System -Translation ScrewEbi, LLC2014221
+4K140645Gibralt Rod-to-Rod Cross ConnectorsExactech Sarasota20141—
+4K133944Range, Spinal System, Everest Spinal SystemK2m, Inc.201433—
+4K132757Everest Spinal SystemK2m, Inc.201341—
+4K132361Everest Spinal SystemK2m, Inc.201334—
+4K132644Lospa IS Pedicle Screw (Monoaxial & Polyaxial), Lospa IS Rod- Straight (Standard), Lospa…Corentec Co., Ltd.20130—
+4K131250Tiger Spine SystemCorelink, LLC201340—
+4K131615Polaris Spinal SystemBiomet Spine (Aka Ebi, LLC)201370—
+4K130887S4C Navigation InstrumentsAesculap Implant System, Inc.201313—
+4K131030Range Spinal SystemK2m, Inc.201334—
+4K130330Range Spinal SystemK2m, Inc.201336—
+4K130291S4 Spinal SystemAesculap Implant System, Inc.201344—
+4K123352S4 Spinal SystemAesculap Implant Systems, Inc.201251—
+4K122226Revere Stabilization SystemGlobus Medical, Inc.2012225—
+4K121016Range Spinal System (Mesa and Denali)K2m, Inc.201238—
+4K121130Polaris Spinal System-Ballista Spinal RodsBiomet Spine20121—
+4K120899Range Spinal System, Unit RodK2m, Inc.201235—
+4K120928Synthes Matrix SystemSynthes Spine20120—
+4K110896Reliance Spinal Screw SystemReliance Medical Systems, LLC20125—
+4K110551Expedium Spine SystemJohnson & Johnson20111—
+4K111571Viper SystemsJohnson & Johnson2011203—
+4K101993Viper System, Expedium SystemDepuy Spine, Inc.20101628
+4K101112Reliance Spinal Screw SystemReliance Medical Systems20107—
+4K092473Expedium Spine SystemDepuy Spine, Inc.2009263—
+4K081978Reliance Spinal Screw SystemReliance Medical Systems, LLC20098—
+4K081898Expedium Spine SystemDepuy Spine, Inc.200859—
+4K073430Valeo Pedicle Screw Spinal SystemAmedica Corp.200824—
+5K261284Invictus® Small Stature Spinal Fixation System; Invictus® 2.0 Spinal Fixation SystemAlphatec Spine, Inc.20260—
+5K260369Dynamis Robotic Surgical SystemLEM Surgical AG20260—
+5K261665CORUS™ Navigation System-GNProvidence Medical Technology, Inc.20260—
+5K260571SIMPACT Sacroiliac Joint Fixation System GX Navigation InstrumentsLife Spine, Inc.20260—
+5K253739SCRIPT™ Rods, CREO™ Stabilization System, REVERE® Stabilization System, REVERE® 4.5…Globus Medical, Inc.20260—
+5K254045CarboClear® Posterior Cervical Screw System; CarboClear® Hybrid Posterior Cervical Screw…CarboFix Orthopedics, Ltd.20260—
+5K253545Vulcan Spinal SystemK2m, Inc.20260—
+5K250599ExcelsiusGPS™ InstrumentsGlobus Medical, Inc.20250—
+5K252346OLYMPIC Posterior Spinal Fixation System; MASADA Modular Spinal Fixation SystemAstura Medical20250—
+5K252437JAZZ Spinal SystemImplanet20250—
+5K251060CORUS™ Navigation System-GXProvidence Medical Technology, Inc.20250—
+5K251719Momentum® Posterior Spinal Fixation SystemUlrich Medical USA, Inc.20250—
+5K243259MASADA Modular Spinal Fixation SystemAstura Medical20250—
+5K243106CarboClear® Hybrid Pedicle Screw SystemCarboFix Orthopedics, Ltd.20240—
+5K230325GREENS BRAND Posterior, Non-cervical Pedicle Screw Spinal SystemGreens Surgicals Pvt., Ltd.20240—
+5K242069Eminent Spine Scoliosis Deformity Pedicle Screw SystemEminent Spine20240—
+5K240180Orthopeasia Spinal Fixation SystemOrthopeasia Co., Ltd.20240—
+5K233793CarboClear® X Pedicle Screw SystemCarboFix Orthopedics, Ltd.20241—
+5K233256Robotic Integration InstrumentsDePuy Synthes20240—
+5K233228Spine Navigation and Robotic-Assistance DeviceEcential Robotics202421
+5K240392JAZZ Spinal SystemImplanet20241—
+5K240872Erisma® Deformity Spinal System; Erisma® Lp Spinal Fixation SystemClariance20241—
+5K233944CarboClear® X Pedicle Screw System; CarboClear® X Navigated InstrumentsCarboFix Orthopedics, Ltd.20243—
+5K231923Liberty SI Lateral Implant SystemSpinal Simplicity, LLC20230—
+5K233078Posterior Cervical Spine SystemDouble Medical Technology, Inc.20231—