510(k) Report

Devices descending from K062196

559 later devices reach SFX Snap-Fit Cross Connector through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+4K243281LOCK-IN Spinal Fixation SystemLock-In USA Corp20240—
+4K242361OZARK Cervical Plate System; PYRENEES® Cervical Plate System; EVEREST® Spinal System…Stryker Spine20241—
+4K240180Orthopeasia Spinal Fixation SystemOrthopeasia Co., Ltd.20240—
+4K240872Erisma® Deformity Spinal System; Erisma® Lp Spinal Fixation SystemClariance20241—
+4K240846CarboClear® Hybrid Pedicle Screw System; CarboClear® Hybrid Navigated Instruments…CarboFix Orthopedics, Ltd.20242—
+4K233989CarboClear® Posterior Cervical Screw SystemCarboFix Orthopedics, Ltd.20242—
+4K234048M.U.S.T. Pedicle Screw System - ExtensionMedacta International S.A.20241—
+4K231443Mini-OSTEO Pedicle Fixation SystemOsteomed Indústria E Comércio DE Implantes Ltda20230—
+4K231494CoreLink Robotic Navigation InstrumentsCorelink, LLC20230—
+4K231809Momentum® Posterior Spinal Fixation System with G21 V-STEADY Bone Cement; Momentum® MIS…Ulrich Medical USA20231—
+4K232218Zenius™ Spinal SystemMedyssey USA, Inc.20230—
+4K231280CarboClear® X Pedicle Screw System; CarboClear® X Navigated Instruments; CarboClear® X…CarboFix Orthopedics, Ltd.20234—
+4K223181NuVasive Reline SystemNu Vasive, Incorporated202311—
+4K223273ASTRA Spine SystemSpinecraft, LLC20228—
+4K213750VyLink™ Spinal Screw SystemVy Spine, LLC20221—
+4K211935ORIO-Ti Intervertebral Body Fusion Cage SystemSpinecraft, LLC20210—
+4K212185Golden Isles Pedicle Screw SystemIntelivation, LLC20210—
+4K211323ASTRA Spine SystemSpinecraft, LLC202112—
+4K210539CoreLink Midline Fixation SystemCorelink, LLC20214—
+4K200789LnK MIS Spinal System, PathLoc-L MIS Spinal System, AccelFix-MIS Spinal SystemL&K BIOMED Co., Ltd.20200—
+4K200596G21 Cement, VADER® Pedicle SystemIcotec AG2020271
+4K201926CarboClear® Pedicle Screw System, CarboClear® II Pedicle Screw SystemCarboFix Orthopedics, Ltd.202010—
+4K201251CarboClear Navigated InstrumentsCarboFix Orthopedics, Ltd.20209—
+4K193423VADER®one Pedicle System MIS and LightMore® Pedicle System 6.0Icotec AG202061
+4K193211Nano FortiFix® SystemNanovis Spine, LLC20201—
+4K190981NEX-D2 Posterior Fixation SystemNext Orthosurgical20200—
+4K192680Percusys® Plus Pedicle Screw SystemJoimax GmbH20190—
+4K193219G Surgical Marksman SystemG Surgical, LLC20191—
+4K192121Black Diamond Pedicle Screw SystemOsseus Fusion Systems201913—
+4K190526High V+ Bone Cement, CarboClear® Fenestrated Pedicle ScrewsCarboFix Orthopedics, Ltd.201928—
+4K190360LineSider™ Spinal SystemIntegrity Implants, Inc.201913—
+4K190545VADER® one Pedicle System MIS and LightMore® Pedicle System 6.0Icotec AG2019291
+4K182974NuVasive Reline SystemNu Vasive, Incorporated201911—
+4K181978Zenius™, Iliad™ and Kora™ Spinal Fixation SystemsMedyssey USA, Inc.20180—
+4K181119Range (Denali and Mesa) Spinal SystemsK2m, Inc.20185—
+4K180376K2M Patient Specific RodsK2m, Inc.20182—
+4K180210CREO® Stabilization SystemGlobus Medical, Inc.201888—
+4K173185SEURAT™ Universal Pedicle Screw SystemCtl Medical Corporation20180—
+4K172469TiLock Modular Spinal SystemGenesys Spine20170—
+4K171832Range/Denali/Mesa Spinal SystemK2m, Inc.201713—
+4K171582NEO Pedicle Screw System™Neo Medical SA20170—
+4K172107Threshold™ V2 Pedicular Fixation System, Threshold™ Pedicular Fixation System, Fortress™…Spineology, Inc.20170—
+4K171838TiLock2 Spinal SystemGenesys Spine20174—
+4K170821ChoiceSpine™ Proliant® Posterior Pedicle Screw and Hook Fixation SystemChoicespine, LP20170—
+4K171438Palisade™ Pedicular Fixation SystemSpineology, Inc.20171—
+4K162995Ibis® Pedicle Screw SystemOrtho Development Corporation20173—
+4K162786PASS LP Spinal SystemMedicrea International SA20176—
+4K162066Reliance Spinal Screw SystemReliance Medical Systems, LLC20163—
+4K160731LumFix Spinal Fixation SytemCG Bio Co., Ltd.20166—
+4K161914Genesys Spine TiLock Cortical Spinal SystemGenesys Spine20161—
+4K161499VertiForm Posterior Fixation SystemNext Orthosurgical20161—
+4K161028K2M Growing Spine SystemK2m, Inc.20163—
+4K161369EVEREST Spinal SystemK2m, Incorporated20169—
+4K153453Inertia Pedicle Screw and Deformity Correxxion SystemNexxt Spine, LLC201617—
+4K153442CD HORIZON Spinal System, Medtronic Navigated Manual Reusable Instruments for Use with…Medtronic Sofamor Danek USA, Inc.201684—
+4K151770Libra Pedicle Screw SystemSpinal Balance, Inc.20151—
+4K152039Genesys Spine TiLock2 Spinal SystemGenesys Spine20157—
+4K151648Altus Spine Pedicle Screw System, Altus Spine MIS Pedicle Screw System, Valencia Pedicle…Altus Partners, LLC20155—
+4K152131Reliance Spinal Screw SystemReliance Medical Systems, LLC20154—
+4K143110GALAXY MIS Screw SystemBm Korea20152—
+4K150325Range/Denali/Mesa Spinal SystemK2m, Inc.201512—
+4K143350Nile Alternative FixationK2m, Inc.201510—
+4K141804Polaris Spinal System - HA CoatedBiomet Spine, LLC201421—
+4K140219Picasso II Mis Spinal SystemAccel Spine20141—
+4K133944Range, Spinal System, Everest Spinal SystemK2m, Inc.201433—
+4K133746Polaris Spinal SystemBiomet Spine (Aka Ebi, LLC)2014671
+4K133350Revere Stabilization SystemGlobus Medical, Inc.201493—
+4K132403Annextm Adjacent Level SystemSpine Wave, Inc.20142—
+4K132884Pathfinder NXT Minimally Invasive Pedicle Screw SystemZimmer Spine, Inc.20130—
+4K131802Expedium, Viper. Viper 2 Spine SystemDepuy Spine, A Johnson & Johnson Company2013139—
+4K131784Range Spinal SystemK2m, Inc.201334—
+4K131878Lliad, Kora, Zenius Pedicle Screw SystemMedyssey USA, Inc.20138—
+4K131538Caplox II Pedicle Screw System/Towerlox Pedicle Screw SystemCaptiva Spine20136—
+4K131343Reform Pedicle Screw SystemSpinal USA201331—
+4K130279Reform Pedicle Screw SystemSpinal USA201331—
+4K124058Creo Stabilization SystemGlobus Medical, Inc.2013172—
+4K131030Range Spinal SystemK2m, Inc.201334—
+4K130330Range Spinal SystemK2m, Inc.201336—
+4K123783Ellipse Occipito-Cerico-Thoracic Spinal System and Capitol ImplantsGlobus Medical, Inc.201397—
+4K123939S4 Spinal SystemAesculap Implant Systems, Inc.20133—
+4K123487Gso GS1 Cannulated Screw SystemGold Standard Orthopaedics, LLC20130—
+4K123412Range Spinal System, Small Strature ComponentsK2m, Inc.201334—
+4K123521Reliance Spinal Screw SystemReliance Medical Systems, LLC20135—
+4K123451Polaris Spinal System - Ballista II RodsBiomet Spine (Aka Ebi, LLC)20120—
+4K122145Lanx Spinal Fixation SystemLanx, Inc.201271
+4K120838Synthes Matrix SystemSynthes Spine201216—
+4K121671Pathfinder NXT Minimally Invasive Pedicle Screw SystemZimmer Spine, Inc.20120—
+4K120564Calypso SystemHogan Lovells US LLP201216—
+4K120928Synthes Matrix SystemSynthes Spine20120—
+4K120571Synthes Uss ConnectorSynthes Spine201274—
+4K113058Tiger Spine SystemCorelink, LLC201281—
+4K120140Focus Spinal SystemL&K BIOMED Co., Ltd.201225—
+4K112551S4 Spinal SystemAesculap Implant System, Inc.201161—
+4K111957Polaris Spinal SystemBiomet Spine (Ebi, LLC)201176—
+4K103671Genesys Spine Tilock SystemGenesys Spine20118—
+4K110283Zenius Spinal SystemMedyssey Co, Ltd.201114—
+4K103272Zenius Spinal SystemMedyssey Co, Ltd.201015—
+5K260989Varion Thoracolumbar Fixation SystemKyocera Medical Technologies Inc. (KMTI)20260—
+5K253739SCRIPT™ Rods, CREO™ Stabilization System, REVERE® Stabilization System, REVERE® 4.5…Globus Medical, Inc.20260—
+5K253940M.U.S.T. Pedicle Screw System - ExtensionMedacta International S.A.20260—