510(k) Report

Devices descending from K962628

905 later devices reach Moss Miami Spinal System through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+3K190360LineSider™ Spinal SystemIntegrity Implants, Inc.201913—
+3K190545VADER® one Pedicle System MIS and LightMore® Pedicle System 6.0Icotec AG2019291
+3K182974NuVasive Reline SystemNu Vasive, Incorporated201911—
+3K181068CREO® Stabilization System, REVERE® Stabilization SystemGlobus Medical, Inc.20182—
+3K180433Ennovate®Aesculap Implant Systems, LLC201811
+3K180210CREO® Stabilization SystemGlobus Medical, Inc.201888—
+3K173185SEURAT™ Universal Pedicle Screw SystemCtl Medical Corporation20180—
+3K173508Everest Spinal SystemK2m20189—
+3K172808CosmoLock Pedicle Screw SystemKalitec Direct, LLC20172—
+3K172101ROMEO® 2 Posterior Osteosynthesis SystemSpineart20179—
+3K171832Range/Denali/Mesa Spinal SystemK2m, Inc.201713—
+3K171582NEO Pedicle Screw System™Neo Medical SA20170—
+3K170861PremierShandong Weigao Orthopaedic Device Co., Ltd.20170—
+3K171758M.U.S.T. Combined Set ScrewsMedacta International S.A.20177—
+3K171369M.U.S.T. MINI Posterior Cervical Screws SystemMedacta International S.A.20178—
+3K170821ChoiceSpine™ Proliant® Posterior Pedicle Screw and Hook Fixation SystemChoicespine, LP20170—
+3K171170M.U.S.T. Pedicle Screw System Extension - Straight Connectors and Additional ScrewsMedacta International S.A.201723—
+3K162995Ibis® Pedicle Screw SystemOrtho Development Corporation20173—
+3K163471Kalitec Direct InSePtion™ MIS Fixation SystemKalitec Direct, LLC20176—
+3K170163Erisma® LP Spinal Fixation SystemClariance, Sas20172—
+3K162786PASS LP Spinal SystemMedicrea International SA20176—
+3K162160Preference Elite Pedicle Screw SystemAmedica Corporation20161—
+3K162061M.U.S.T. Pedicle Screw SystemMedacta International S.A.201615—
+3K161387Mont Blanc and Mont Blanc MIS Spinal SystemsSpineway SA20163—
+3K161028K2M Growing Spine SystemK2m, Inc.20163—
+3K160775Thunderbolt™ Minimally Invasive and Lancer™ Open Pedicle Screw SystemsChoicespine, LP201673—
+3K153453Inertia Pedicle Screw and Deformity Correxxion SystemNexxt Spine, LLC201617—
+3K153664M.U.S.T. Pedicle Screw SystemMedacta International201624—
+3K152632XIA 4.5 Spinal Fixation System, Power Adaaptor Instrument AccessoryStryker Corporation201531—
+3K151770Libra Pedicle Screw SystemSpinal Balance, Inc.20151—
+3K151727Everest Spinal SystemK2m, Inc.201511—
+3K143110GALAXY MIS Screw SystemBm Korea20152—
+3K150325Range/Denali/Mesa Spinal SystemK2m, Inc.201512—
+3K143350Nile Alternative FixationK2m, Inc.201510—
+3K142381Xia 3 Spinal SystemStryker Corp.201483—
+3K141291Vertiform Posterior Fixation SystemNext Orthosurgical20142—
+3K141988M.U.S.T Pedicle Screw SystemMedacta International201426—
+3K132788Myspine Pedicle Screw Placement GuidesMedacta International201412—
+3K140238Excella Iii-D Spinal Deformity SystemInnovasis, Inc.201432
+3K140219Picasso II Mis Spinal SystemAccel Spine20141—
+3K133366Orthros Posterior Stabilization SystemCamber Spine20142—
+3K133944Range, Spinal System, Everest Spinal SystemK2m, Inc.201433—
+3K133746Polaris Spinal SystemBiomet Spine (Aka Ebi, LLC)2014671
+3K133350Revere Stabilization SystemGlobus Medical, Inc.201493—
+3K132884Pathfinder NXT Minimally Invasive Pedicle Screw SystemZimmer Spine, Inc.20130—
+3K132644Lospa IS Pedicle Screw (Monoaxial & Polyaxial), Lospa IS Rod- Straight (Standard), Lospa…Corentec Co., Ltd.20130—
+3K131802Expedium, Viper. Viper 2 Spine SystemDepuy Spine, A Johnson & Johnson Company2013139—
+3K131250Tiger Spine SystemCorelink, LLC201340—
+3K131784Range Spinal SystemK2m, Inc.201334—
+3K131343Reform Pedicle Screw SystemSpinal USA201331—
+3K130279Reform Pedicle Screw SystemSpinal USA201331—
+3K131030Range Spinal SystemK2m, Inc.201334—
+3K130330Range Spinal SystemK2m, Inc.201336—
+3K123783Ellipse Occipito-Cerico-Thoracic Spinal System and Capitol ImplantsGlobus Medical, Inc.201397—
+3K123939S4 Spinal SystemAesculap Implant Systems, Inc.20133—
+3K123412Range Spinal System, Small Strature ComponentsK2m, Inc.201334—
+3K121670Medyssey Cannulated Pedicle ScrewMedyssey Co, Ltd.201311—
+3K123451Polaris Spinal System - Ballista II RodsBiomet Spine (Aka Ebi, LLC)20120—
+3K122226Revere Stabilization SystemGlobus Medical, Inc.2012225—
+3K122145Lanx Spinal Fixation SystemLanx, Inc.201271
+3K120838Synthes Matrix SystemSynthes Spine201216—
+3K121922Beacon Stabilization SystemGlobus Medical, Inc.20129—
+3K121671Pathfinder NXT Minimally Invasive Pedicle Screw SystemZimmer Spine, Inc.20120—
+3K120564Calypso SystemHogan Lovells US LLP201216—
+3K121342Xia 4.5 Spinal SystemStryker Corp.201288—
+3K113395Revere 4.5 Stabilization SystemGlobus Medical, Inc.2012260—
+3K120928Synthes Matrix SystemSynthes Spine20120—
+3K120571Synthes Uss ConnectorSynthes Spine201274—
+3K121020Viper SystemDepuy Spine, Inc.201294—
+3K113058Tiger Spine SystemCorelink, LLC201281—
+3K120434Power Adaptor Instrument AccessoryStryker Corp.201232—
+3K120140Focus Spinal SystemL&K BIOMED Co., Ltd.201225—
+3K110896Reliance Spinal Screw SystemReliance Medical Systems, LLC20125—
+3K112551S4 Spinal SystemAesculap Implant System, Inc.201161—
+3K111957Polaris Spinal SystemBiomet Spine (Ebi, LLC)201176—
+3K111449Revolve Additional ImplantsGlobus Medical, Inc.2011236—
+3K111479Revere CrosstopGlobus Medical, Inc.2011232—
+3K111478Stryker Spine Power Adaptor (Accessory Instrument)Stryker Corporation201134—
+3K110842Atlas Spine Pedicle Screw SystemAtlas Spine, Inc.20114—
+3K110280Revlok Fenestrated Screw SystemGlobus Medical, Inc.201195—
+3K103072Revere Sacral PlatesGlobus Medical, Inc.2011233—
+3K101112Reliance Spinal Screw SystemReliance Medical Systems20107—
+3K102248Excella II Spinal System Model EC2-00Innovasis, Inc.201043
+3K100788Cocr RodsGlobus Medical, Inc.2010374—
+3K100737Modification to: Trio+Spinal Fixation SystemStryker Spine201086—
+3K092076Aegis & Aegis II Spinal SystemCorentec Co., Ltd.20103—
+3K093294Revere Stabilization SystemGlobus Medical, Inc.2010376—
+3K091782Revere 6.35 Stabilization SystemGlobus Medical, Inc.2009404—
+3K092108Truss Thoracolumbar Plate SystemGlobus Medical, Inc.200942—
+3K091291Xia 3 Spinal System, Uniplanner/Reduction Screws & Vitallium RodStryker Spine2009169—
+3K081978Reliance Spinal Screw SystemReliance Medical Systems, LLC20098—
+3K073439Transition Stabilization SystemGlobus Medical, Inc.20092—
+3K083416Revolve Stabilization SystemGlobus Medical, Inc.2009297—
+3K081883Modification to Preference Pedicle Screw SystemUs Spine20082—
+3K081195Revere Uniplanar ScrewsGlobus Medical, Inc.2008405—
+3K080767Conquest Spinal SystemLife Spine200821—
+3K073517H-Link Integrated RodGlobus Medical, Inc.20080—
+3K073172Beacon Stabilization SystemGlobus Medical, Inc.2007376—
+3K073151Mantis Spinal SystemStryker Corp.2007111—
+3K071373Stryker Spine Xia Iii Spinal SystemStryker Spine20074301