510(k) Report

Devices descending from K983583

965 later devices reach Depuy Acromed Moss and Moss Miami Spinal Systems through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+2K093926Firebird Spinal Fixation SystemBlackstone Medical, Inc.201088—
+2K100623Aesculap Implant Systems S4 Spinal SystemAesculap Implant Systems2010921
+2K100377Diamondback Spinal SystemEminent Spine201029—
+2K092825Apex Spine System 5.50 MM Titanium Rod & Polyaxial Screw WasherSpinecraft, Inc.2010178—
+2K092473Expedium Spine SystemDepuy Spine, Inc.2009263—
+2K070385TI-Tamed Spinal SystemTi-Tamed (Pty), Ltd.20090—
+2K091110Spinal Edge Titan Pedicle Screw SystemSpinal Edge, LLC20091—
+2K0910675.5 Polaris Spinal SystemBiomet Spine200979—
+2K081978Reliance Spinal Screw SystemReliance Medical Systems, LLC20098—
+2K082353Mercury Spinal SystemSpinal Elements, Inc.200911—
+2K083230Mercury Spinal SystemSpinal Elements, Inc.200811—
+2K071074Mykres Spinal SystemShowa Ika Kohgyo Co., Ltd.20080—
+2K080773Thor Anterior Plating SystemStryker Spine2008101—
+2K081252Expedium 4.5MM Spine SystemDepuy Spine, Inc.200844—
+2K073437Thor Anterior Plating SystemStryker Spine200810231
+2K071921Innovasis Excella Spinal System, Excella-M (Monoaxial Screws), Excella-P (Polyaxial…Innovasis, Inc.20075—
+2K071890Zodiac 4.0 Polyaxial Spinal Fixation SystemAlphatec Spine, Inc.20071801
+2K072081Zodiac Dynamo Semi-Rigid Spinal SystemAlphatec Spine, Inc.20071—
+2K063668Roc Lumbar SystemAlphatec Spine, Inc.20070—
+2K070245Capsure Pedicle Screw SystemSpine Wave, Inc.200742—
+2K062513Apex Spine SystemSpinecraft, Inc.2006179—
+2K061774Nfix II Pedicle Screw SystemN Spine, Inc.200627
+2K062174Modification to Expedium Spine SystemDepuy Spine, Inc.2006490—
+2K061342Malibu Spinal SystemSeaspine, Inc.2006801
+2K051942Malibu Spinal SystemSeaspine, Inc.20058111
+2K051663Malibu Spinal SystemSeaspine, Inc.200581—
+2K042143Excella-M Spinal SystemInnovasis, Inc.20046—
+2K033352Vertebron PSS Pedicle Screw SystemVertebron, Inc.200462—
+2K032604Gii Spinal Fixation SystemCo-Ligne AG20045—
+2K024348Monarch Spine SystemDepuyacromed2003578—
+2K023438Modification to Monarch Spine SystemDepuyacromed20024—
+2K021879Crossover Cross Connector (Isola Spinal System)Depuyacromed20021—
+2K021880Crossover Cross Connector (Moss Miami Spine System)Depuyacromed20024—
+2K021148Monarch Spine System Commercially Pure Titanium Spinal RodDepuyacromed2002496—
+2K013441Isola Polyaxial WasherDepuyacromed2001262—
+2K013444Isobar Spinal SystemScien'Tx USA, Inc.200194—
+2K002824Macs Modular Anterior Construct SystemAesculap, Inc.2001254—
+3K253739SCRIPT™ Rods, CREO™ Stabilization System, REVERE® Stabilization System, REVERE® 4.5…Globus Medical, Inc.20260—
+3K252730Fule Spinal Fixation SystemBeijing Fule Science & Technology Development Co., Ltd.20250—
+3K250908Virata Spinal Fixation SystemSeaSpine Orthopedics Corporation202521
+3K242900VADER® Pedicle System and VADER®one Pedicle SystemIcotec AG20250—
+3K242069Eminent Spine Scoliosis Deformity Pedicle Screw SystemEminent Spine20240—
+3K241034Meta+ Bone Cement & M.U.S.T. Fenestrated Pedicle Screw SystemMedacta International S.A.20242—
+3K241258Ingenix Spinal SystemIngenium Spine20240—
+3K241175MiRus MoRe Lumbar Plating SystemMiRus, LLC20240—
+3K232256Alcantara Thoracolumbar Plate SystemCamber Spine Technologies, LLC20240—
+3K240737G Surgical Marksman MIS SystemG Surgical, LLC20240—
+3K233360Curiteva Thoracolumbar Plate SystemCuriteva, Inc.20240—
+3K231443Mini-OSTEO Pedicle Fixation SystemOsteomed Indústria E Comércio DE Implantes Ltda20230—
+3K232318VICTORY™ Lumbar Plate SystemGlobus Medical, Inc.20230—
+3K231494CoreLink Robotic Navigation InstrumentsCorelink, LLC20230—
+3K231799INERTIA® CONNEXX™ Modular Pedicle Screw SystemNexxt Spine, LLC20230—
+3K231844ProMIS™ Fixation SystemPremia Spine, Ltd.20231—
+3K230063G Surgical Marksman Spinal Deformity SystemG Surgical, LLC20230—
+3K223181NuVasive Reline SystemNu Vasive, Incorporated202311—
+3K223719Paeon Anterior Cervical Plate System, Elatus Lumbar Plate SystemAegis Spine, Inc.20233—
+3K223273ASTRA Spine SystemSpinecraft, LLC20228—
+3K222516Mercury® II Spinal SystemSpinal Elements, Inc.20223—
+3K221728Aviator® Anterior Cervical Plating (ACP) System, LITe® Plate System, DynaTran™ Anterior…Stryker Corporation20221—
+3K211027Altus Spine Pedicle Screw SystemAltus Partners, LLC20222—
+3K221905INERTIA CONNEXX Modular Pedicle Screw SystemNexxt Spine, LLC20221—
+3K220570M.U.S.T. MINI Posterior Cervical Screws System ExtensionMedacta International S.A.20220—
+3K220324AccuFit Lateral 2-Hole PlatePrecision Spine, Inc.20223—
+3K213750VyLink™ Spinal Screw SystemVy Spine, LLC20221—
+3K211935ORIO-Ti Intervertebral Body Fusion Cage SystemSpinecraft, LLC20210—
+3K203607MOSS VRS Spinal SystemBiedermann Motech GmbH & Co. KG20210—
+3K210963ENNOVATE Spinal SystemAesculap Implant Systems, LLC20210—
+3K211323ASTRA Spine SystemSpinecraft, LLC202112—
+3K210306GII Spinal Fixation SystemColigne AG20210—
+3K210539CoreLink Midline Fixation SystemCorelink, LLC20214—
+3K203561ChoiceSpine Navigation SystemChoice Spine, LLC20211—
+3K203452Nano FortiFix® SystemNanovis, LLC20200—
+3K200789LnK MIS Spinal System, PathLoc-L MIS Spinal System, AccelFix-MIS Spinal SystemL&K BIOMED Co., Ltd.20200—
+3K203149M.U.S.T. MINI Posterior Cervical Screws SystemMedacta International S.A.20200—
+3K192481AccelFix Lumbar Plate SystemL&K BIOMED Co., Ltd.202013—
+3K193211Nano FortiFix® SystemNanovis Spine, LLC20201—
+3K200267LOSPA® IS™ Spinal Fixation SystemCorentec Co., Ltd.20201—
+3K200130M.U.S.T. MINI Posterior Cervical Screws SystemMedacta International S.A.20206—
+3K192680Percusys® Plus Pedicle Screw SystemJoimax GmbH20190—
+3K192121Black Diamond Pedicle Screw SystemOsseus Fusion Systems201913—
+3K191932Momentum™ Posterior Spinal Fixation SystemUlrich Medical USA20192—
+3K191576Mercury® Spinal System, Overwatch® Spinal SystemSpinal Elements, Inc.20195—
+3K190360LineSider™ Spinal SystemIntegrity Implants, Inc.201913—
+3K190016Lateral Plate SystemCorelink, LLC201915—
+3K190584CAYMAN LP Plate SystemK2m, Inc.20192—
+3K182974NuVasive Reline SystemNu Vasive, Incorporated201911—
+3K182837M.U.S.T. Mini ExtensionMedacta International S.A.20191—
+3K183214Raven Lumbar Plate SystemChoicespine, LP20192—
+3K180754C-Zero Pedicle Screw System, Freedom Pedicle Screw SystemSignature Orthopaedics Pty, Ltd.20180—
+3K182598VersaLink™ Fixation SystemPremia Spine, Ltd.20180—
+3K181677Kodiak Spinal Fixation SystemAlphatec Spine, Inc.201870—
+3K180686SeaSpine Daytona Small Stature Spinal SystemSeaSpine Orthopedics Corporation201812—
+3K180433Ennovate®Aesculap Implant Systems, LLC201811
+3K180458FOCUS Pedicle Screw SystemNvision Biomedical Technologies, LLC20181—
+3K172967Mercury® Spinal SystemSpinal Elements, Inc.20185—
+3K180324Patriot Spinal Fixation SystemValorus Spine20180—
+3K173885Genesys Spine Binary Lumbar Plate SystemGenesys Spine20184—
+3K180176SeaSpine NewPort Spinal SystemSeaSpine Orthopedics Corporation20180—
+3K173185SEURAT™ Universal Pedicle Screw SystemCtl Medical Corporation20180—
+3K173882SeaSpine Mariner Pedicle Screw SystemSeaSpine Orthopedics Corporation2018561