510(k) Report

Devices descending from K962628

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

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K191212CrossOver Cross Connectors, DePuy PULSE Thoracolumbar Screw System, EXPEDIUM Fenestrated…Medos International SARL20190—
+1K112684Mont Blanc Pedicle Screw SystemsQualgenix20125—
+1K090648Viper 2 SystemDepuy Spine, Inc.2009337—
+1K090230Expedium Spine SystemDepuy Spine, Inc.2009462—
+1K080241DDS Stabilization SystemParadigm Spine, LLC20085—
+1K072022Valeo Pedicle Screw Spinal SystemAmedica Corp.2007100—
+1K060748Modification to Xia 4.5 Spinal SystemStryker Spine2006134—
+1K053115Xia Spinal SystemStryker Spine2005889—
+1K050461Xia 4.5 Spinal SystemStryker Spine2005742—
+2K240233Pitkar Spinal Pedicle Screw SystemS.H.Pitkar Orthotools Pvt., Ltd.20240—
+2K210427M.U.S.T. Midline Cortical (MC) Screw SystemMedacta International S.A.20210—
+2K190636NuVasive® Reline® 4.5-5.0 SystemNu Vasive, Incorporated201913—
+2K181139OLYMPIC Posterior Spinal Fixation SystemAstura Medical, LLC20188—
+2K180153X-spine Cortical Bone Screw SystemX-Spine Systems, Inc.20180—
+2K170126NuVasive® Reline® 4.5-5.0 SystemNu Vasive, Incorporated201739—
+2K162134ENNOVATE Spinal SystemAesculap Implant Systems, LLC20162—
+2K151362HC Spinal SystemHung Chun Bio-S Co., Ltd.20160—
+2K151977icotec Pedicle SystemIcotec AG201630—
+2K160124LUMIS Cannulated Pedicle Screw Fixation System, U.L.I.S. Pedicle Screw Fixation SystemSpinevision S.A.20162—
+2K143683APEX-DL Spine SystemSpinecraft, LLC20153—
+2K150417Astra Spine SystemSpinecraft, LLC201521—
+2K150185Mont Blanc Spinal SystemSpineway20154—
+2K143200MIS Z-Pedicle Screw SystemZ-Medical GmbH & Co. KG201514—
+2K141044M.U.S.T. ExtensionMedacta International201416—
+2K133575Spinevision Lumis Cannulated Pedicle Screw Fixation System, Spinevision U.L.I.S. Pedicle…Spinevision S.A.20143—
+2K140678Cosmolock Pedicle Screw SystemKalitec Direct, LLC201410—
+2K133103Aversion Pedicle Screw SystemK7, LLC20140—
+2K133369Tiger Spine SystemCorelink, LLC201429—
+2K132878M.U.S.T. ExtensionMedacta International201328—
+2K133188Mantis & Mantis Redux Spinal System, Radius Spinal System, Trio & Trio+ Spinal Fixation…Stryker Spine201384—
+2K132603Apex Spine SystemSpinecraft, LLC201325—
+2K131810Osseus Black Diamond Pedicle Screw SystemOsseus Fusion Systems, LLC201314—
+2K130877Expedium Spine SystemMedos International SARL20138—
+2K122877Range Spinal System, Small StatureK2m, Inc.201334—
+2K120714Picasso Mis Spinal Fixation SystemAccel Spine20122—
+2K121115M.U.S.T Pedicle Screw SystemMedacta International2012431
+2K121130Polaris Spinal System-Ballista Spinal RodsBiomet Spine20121—
+2K120099Range Spinal System (Mesa and Denali)K2m, Inc.201253—
+2K120491DSS Stabilization System-RigidParadigm Spine, LLC20120—
+2K113625DSS Stabilization SystemParadigm Spine, LLC20121—
+2K112643Focus Mis SystemL&K BIOMED Co., Ltd.201226—
+2K113044Synthes MirsSynthes Spine2011933
+2K110551Expedium Spine SystemJohnson & Johnson20111—
+2K110906Apex Spine SystemSpinecraft, LLC2011103—
+2K110216Expedium System, Viper SystemDepuy Spine, Inc.20114—
+2K103292Trio Trauma Spinal SystemStryker Corporation201185—
+2K103133Veper System, Expedium SystemDepuy Spine, Inc.20110—
+2K101993Viper System, Expedium SystemDepuy Spine, Inc.20101628
+2K102701Viper Spine SystemDepuy Spine, Inc.2010184—
+2K100845Pathfinder II, Minimally Invasie Pedicle Screw System Model 3500 SeriesZimmer Spine, Inc.201045
+2K101070Expedium Spine SystemMedos International SARL20102601
+2K101083DSS Stabilization SystemParadigm Spine, LLC20102—
+2K100623Aesculap Implant Systems S4 Spinal SystemAesculap Implant Systems2010921
+2K092605Xia 4.5 Spinal SystemStryker Spine200998—
+2K092473Expedium Spine SystemDepuy Spine, Inc.2009263—
+2K083077Ulc Spinal Pedicle Screw SystemOtis Biotech Co., Ltd.20090—
+2K091944Modification to: DSS Stabilization SystemParadigm Spine, LLC20093—
+2K0910675.5 Polaris Spinal SystemBiomet Spine200979—
+2K090408Modification to: DSS Stabilization SystemParadigm Spine, LLC20094—
+2K080928Xia Spinal System, Stainless Steel Uni-Planar ScrewsStryker Spine2008182—
+2K073430Valeo Pedicle Screw Spinal SystemAmedica Corp.200824—
+2K071921Innovasis Excella Spinal System, Excella-M (Monoaxial Screws), Excella-P (Polyaxial…Innovasis, Inc.20075—
+2K062698Trio + Spinal SystemStryker Spine2006882
+2K061202Revere Stabilization SystemGlobus Medical, Inc.2006547—
+2K060361Xia Spinal System, Xia 4.5 Spinal SystemStryker Spine20067341
+2K052761Modification to: Xia 4.5 Spinal SystemStryker Spine2005735—
+3K253739SCRIPT™ Rods, CREO™ Stabilization System, REVERE® Stabilization System, REVERE® 4.5…Globus Medical, Inc.20260—
+3K253940M.U.S.T. Pedicle Screw System - ExtensionMedacta International S.A.20260—
+3K242900VADER® Pedicle System and VADER®one Pedicle SystemIcotec AG20250—
+3K242764MediRod Pedicle Screw SystemCmf Medicon Surgical, Inc.20240—
+3K241034Meta+ Bone Cement & M.U.S.T. Fenestrated Pedicle Screw SystemMedacta International S.A.20242—
+3K234048M.U.S.T. Pedicle Screw System - ExtensionMedacta International S.A.20241—
+3K232572Kalitec Navigated Instrument SystemKalitec Direct, LLC Doing Business AS Kalitec Medical20230—
+3K231443Mini-OSTEO Pedicle Fixation SystemOsteomed Indústria E Comércio DE Implantes Ltda20230—
+3K231694MASADA Modular Spinal Fixation SystemAstura Medical20232—
+3K231494CoreLink Robotic Navigation InstrumentsCorelink, LLC20230—
+3K230974NIDO™ Pedicle Screw SystemKalitec Medical20230—
+3K231636LnK Spinal Fixation System /OpenLoc-L Spinal Fixation System, AccelFix Spinal Fixation…L&K BIOMED Co., Ltd.20232—
+3K222684XIA® 4.5 Spinal System, XIA® 4.5 Cortical Trajectory, XIA® 3 Spinal System, Serrato®…Stryker Spine20234—
+3K230245LnK Spinal Fixation System/OpenLoc-L Spinal Fixation System; AccelFix Spinal Fixation…L&K BIOMED Co., Ltd.20233—
+3K223181NuVasive Reline SystemNu Vasive, Incorporated202311—
+3K222789VADER® Pedicle System, G21 CementIcotec AG202352
+3K223273ASTRA Spine SystemSpinecraft, LLC20228—
+3K220285PINE Pedicle Screw SystemTdm Co., Ltd.20220—
+3K213820BALTEUM - ONE™ Lumbar Plate SystemHuvexel Co., Ltd.20223—
+3K211935ORIO-Ti Intervertebral Body Fusion Cage SystemSpinecraft, LLC20210—
+3K210963ENNOVATE Spinal SystemAesculap Implant Systems, LLC20210—
+3K211323ASTRA Spine SystemSpinecraft, LLC202112—
+3K210420Goblin and Goblin LS Pedicle Screw SystemsMedynus, Inc.20211—
+3K203482M.U.S.T. Pedicle Screw Extension and Long Tab ImplantsMedacta International S.A.20215—
+3K200789LnK MIS Spinal System, PathLoc-L MIS Spinal System, AccelFix-MIS Spinal SystemL&K BIOMED Co., Ltd.20200—
+3K200596G21 Cement, VADER® Pedicle SystemIcotec AG2020271
+3K193423VADER®one Pedicle System MIS and LightMore® Pedicle System 6.0Icotec AG202061
+3K193211Nano FortiFix® SystemNanovis Spine, LLC20201—
+3K200267LOSPA® IS™ Spinal Fixation SystemCorentec Co., Ltd.20201—
+3K193365M.U.S.T. Pedicle Screw SystemMedacta International S.A.20207—
+3K192680Percusys® Plus Pedicle Screw SystemJoimax GmbH20190—
+3K193219G Surgical Marksman SystemG Surgical, LLC20191—
+3K192121Black Diamond Pedicle Screw SystemOsseus Fusion Systems201913—
+3K191932Momentum™ Posterior Spinal Fixation SystemUlrich Medical USA20192—