510(k) Report

Devices descending from K070229

598 later devices reach Range Spinal System through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+3K101070Expedium Spine SystemMedos International SARL20102601
+3K093926Firebird Spinal Fixation SystemBlackstone Medical, Inc.201088—
+3K100623Aesculap Implant Systems S4 Spinal SystemAesculap Implant Systems2010921
+3K100044Firebird Spinal Fixation System, Firebird Side-Loading BodyBlackstone2010117—
+3K092473Expedium Spine SystemDepuy Spine, Inc.2009263—
+3K0910675.5 Polaris Spinal SystemBiomet Spine200979—
+3K090648Viper 2 SystemDepuy Spine, Inc.2009337—
+4K261284Invictus® Small Stature Spinal Fixation System; Invictus® 2.0 Spinal Fixation SystemAlphatec Spine, Inc.20260—
+4K261130AccelFix Spinal Fixation SystemL&K BIOMED Co., Ltd.20260—
+4K253940M.U.S.T. Pedicle Screw System - ExtensionMedacta International S.A.20260—
+4K242516EUROPA™ Posterior Cervical Fusion SystemMiRus, LLC20242—
+4K240233Pitkar Spinal Pedicle Screw SystemS.H.Pitkar Orthotools Pvt., Ltd.20240—
+4K233793CarboClear® X Pedicle Screw SystemCarboFix Orthopedics, Ltd.20241—
+4K240872Erisma® Deformity Spinal System; Erisma® Lp Spinal Fixation SystemClariance20241—
+4K233508iFuse Bedrock Granite® Implant SystemSI-BONE, Inc.20245—
+4K233944CarboClear® X Pedicle Screw System; CarboClear® X Navigated InstrumentsCarboFix Orthopedics, Ltd.20243—
+4K231443Mini-OSTEO Pedicle Fixation SystemOsteomed Indústria E Comércio DE Implantes Ltda20230—
+4K231744VyLink™ Spinal Screw SystemVy Spine, LLC20230—
+4K231799INERTIA® CONNEXX™ Modular Pedicle Screw SystemNexxt Spine, LLC20230—
+4K223181NuVasive Reline SystemNu Vasive, Incorporated202311—
+4K221776NextGen Pedicle Screw SystemCorelink, LLC20222—
+4K211710Ascent POCT System, Centurion POCT System, Spinal Fixation System (SFS), Firebird Spinal…Orthofix, Inc.20212—
+4K210874Reliance Spinal Screw SystemReliance Medical Systems, LLC20212—
+4K201427Trivergent Spinal Fixation SystemBenvenue Medical, Inc.20202—
+4K200596G21 Cement, VADER® Pedicle SystemIcotec AG2020271
+4K193423VADER®one Pedicle System MIS and LightMore® Pedicle System 6.0Icotec AG202061
+4K200303Reform Pedicle Screw SystemPrecision Spine202010—
+4K200267LOSPA® IS™ Spinal Fixation SystemCorentec Co., Ltd.20201—
+4K192268Europa Pedicle Screw SystemMiRus, LLC20190—
+4K191212CrossOver Cross Connectors, DePuy PULSE Thoracolumbar Screw System, EXPEDIUM Fenestrated…Medos International SARL20190—
+4K191757EUROPA Pedicle Screw SystemMiRus, LLC20191—
+4K190360LineSider™ Spinal SystemIntegrity Implants, Inc.201913—
+4K190545VADER® one Pedicle System MIS and LightMore® Pedicle System 6.0Icotec AG2019291
+4K190762The JASPER Spinal Fixation System IIGbs Commonwealth Co., Ltd.20191—
+4K182974NuVasive Reline SystemNu Vasive, Incorporated201911—
+4K182239OLYMPIC Posterior Spinal Fixation SystemAstura Medical, LLC20182—
+4K182240PASS LP Spinal SystemMedicrea International SA20182—
+4K182059Prase MIS Spinal SystemGbs Commonwealth Co., Ltd.20182—
+4K180433Ennovate®Aesculap Implant Systems, LLC201811
+4K173180Mega Plus Spine SystemBk Meditech, Co., Ltd.20183—
+4K180153X-spine Cortical Bone Screw SystemX-Spine Systems, Inc.20180—
+4K172469TiLock Modular Spinal SystemGenesys Spine20170—
+4K172417SILC® Fixation SystemGlobus Medical, Inc.20171—
+4K170861PremierShandong Weigao Orthopaedic Device Co., Ltd.20170—
+4K171813OpenLoc-L Spinal Fixation System, LnK Spinal Fixation SystemL&K BIOMED Co., Ltd.201730—
+4K170821ChoiceSpine™ Proliant® Posterior Pedicle Screw and Hook Fixation SystemChoicespine, LP20170—
+4K170647Connector SystemOrthofix, Inc.201718—
+4K170163Erisma® LP Spinal Fixation SystemClariance, Sas20172—
+4K161516G Surgical Marksman MIS SystemG Surgical, LLC20163—
+4K151977icotec Pedicle SystemIcotec AG201630—
+4K153323Palisade Pedicular Fixation SystemSpineology, Inc.20167—
+4K153525Seneka II Polyscrew Pedicle Fixation SystemSenecka Spine20160—
+4K150184Dymaxeon Spine SystemBack 2 Basics Direct, LLC201541
+4K141222Nautilus Spinal System and Solstice Oct SystemLife Spine, Inc.201513—
+4K143200MIS Z-Pedicle Screw SystemZ-Medical GmbH & Co. KG201514—
+4K142146Ibis Pedicle Screw SystemOrtho Development Corp.20145—
+4K141291Vertiform Posterior Fixation SystemNext Orthosurgical20142—
+4K140123Polaris Spinal System -Translation ScrewEbi, LLC2014221
+4K140696Streamline TL Spinal Fixation SystemPioneer Surgical Technology, Inc.20145—
+4K133746Polaris Spinal SystemBiomet Spine (Aka Ebi, LLC)2014671
+4K131833Centurion Poct SystemOrthofix, Inc.20142—
+4K133103Aversion Pedicle Screw SystemK7, LLC20140—
+4K133369Tiger Spine SystemCorelink, LLC201429—
+4K131250Tiger Spine SystemCorelink, LLC201340—
+4K131615Polaris Spinal SystemBiomet Spine (Aka Ebi, LLC)201370—
+4K131785Pagoda Pedicle Screw SystemOrtho Development Corp.20136—
+4K131810Osseus Black Diamond Pedicle Screw SystemOsseus Fusion Systems, LLC201314—
+4K130932Firebird Spinal Fixation SystemOrthofix, Inc.2013811
+4K131343Reform Pedicle Screw SystemSpinal USA201331—
+4K130279Reform Pedicle Screw SystemSpinal USA201331—
+4K130176Firebird Spinal Fixation SystemOrthofix20135—
+4K123939S4 Spinal SystemAesculap Implant Systems, Inc.20133—
+4K121670Medyssey Cannulated Pedicle ScrewMedyssey Co, Ltd.201311—
+4K121786Dymaxeon Spine SystemB2b Spine Pty, Ltd.20125—
+4K122226Revere Stabilization SystemGlobus Medical, Inc.2012225—
+4K120714Picasso Mis Spinal Fixation SystemAccel Spine20122—
+4K120564Calypso SystemHogan Lovells US LLP201216—
+4K121130Polaris Spinal System-Ballista Spinal RodsBiomet Spine20121—
+4K121020Viper SystemDepuy Spine, Inc.201294—
+4K112643Focus Mis SystemL&K BIOMED Co., Ltd.201226—
+4K113044Synthes MirsSynthes Spine2011933
+4K112551S4 Spinal SystemAesculap Implant System, Inc.201161—
+4K111957Polaris Spinal SystemBiomet Spine (Ebi, LLC)201176—
+4K110216Expedium System, Viper SystemDepuy Spine, Inc.20114—
+4K103133Veper System, Expedium SystemDepuy Spine, Inc.20110—
+4K101993Viper System, Expedium SystemDepuy Spine, Inc.20101628
+4K100845Pathfinder II, Minimally Invasie Pedicle Screw System Model 3500 SeriesZimmer Spine, Inc.201045
+5K262067iFuse Granite Onyx™ Implant SystemSI-BONE, Inc.20260—
+5K254274ARx® SAI Implant SystemLife Spine, Inc.20260—
+5K253169Duet™ Spinal Fixation SystemBox Spine, LLC20261—
+5K252327CMORE® CT System; CMORE® CT System Navigated InstrumentsIcotec AG20251—
+5K252088Firebird SI Navigation SystemOrthofix US, LLC20251—
+5K252322SIros-X SystemGenesys Spine20250—
+5K252346OLYMPIC Posterior Spinal Fixation System; MASADA Modular Spinal Fixation SystemAstura Medical20250—
+5K242827A8 INTEGR8™ Porous Pedicle ScrewsAllumin8, Inc.20251—
+5K253094iFuse Bedrock Granite Implant SystemSI-BONE, Inc.20250—
+5K250866Sovereign Posterior Cervical SystemMet One Technologies, LLC20251—
+5K242900VADER® Pedicle System and VADER®one Pedicle SystemIcotec AG20250—
+5K243259MASADA Modular Spinal Fixation SystemAstura Medical20250—
+5K242297Reform Pedicle Screw SystemPrecision Spine, Inc.20240—