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
+4K192800Streamline TL Spinal Fixation SystemPioneer Surgical Technology, Inc. (Dba Rti Surgical, Inc.)20203—
+4K192938Invictus™ Spinal Fixation SystemAlphatec Spine, Inc.201969—
+4K192396Streamline MIS Spinal Fixation SystemPioneer Surgical Technology, Inc.20190—
+4K192281AEGIS Anterior Lumbar Plate System, ALC Dynamized Fixation System, Anterior ISOLA Spine…Medos International SARL20190—
+4K192678Genesys Spine Binary® Lumbar Plate SystemGenesys Spine20191—
+4K191726mont blanc & mont blanc MIS Spinal SystemsSpineway SA20190—
+4K191575ARx Spinal SystemLife Spine, Inc.201910—
+4K191648Mariner MIS Pedicle Screw System; SeaSpine Navigation SystemSeaSpine Orthopedics Corporation201949—
+4K190545VADER® one Pedicle System MIS and LightMore® Pedicle System 6.0Icotec AG2019291
+4K183639Mariner Outrigger Revision SystemSeaSpine Orthopedics Corporation20198—
+4K180498NuVasive Reline Fenestrated Screws, High V+ Bone CementNu Vasive, Incorporated201841—
+4K182239OLYMPIC Posterior Spinal Fixation SystemAstura Medical, LLC20182—
+4K182240PASS LP Spinal SystemMedicrea International SA20182—
+4K181603EVEREST Spinal System, RANGE (MESA and DENALI) Spinal System, CASPIAN OCT (MESA Mini and…K2m, Inc.20185—
+4K181980OsseoScrew SystemAlphatec Spine, Inc.20181—
+4K181390Response Spine System, Response 5.5/6.0 Spine System, Response 4.5/5.0 Spine SystemOrthoPediatrics Corp.201813—
+4K181821MOSS VRS Spinal SystemBiedermann Motech GmbH & Co. KG20181—
+4K181435ATEC Cervical Spacer SystemAlphatec Spine, Inc.2018100—
+4K181339Altus Spine Pedicle Screw SystemAltus Partners, LLC20186—
+4K173645JASPER Spinal Fixation SystemGbs Commonwealth Co., Ltd.20183—
+4K181139OLYMPIC Posterior Spinal Fixation SystemAstura Medical, LLC20188—
+4K181068CREO® Stabilization System, REVERE® Stabilization SystemGlobus Medical, Inc.20182—
+4K181119Range (Denali and Mesa) Spinal SystemsK2m, Inc.20185—
+4K181281Altus Spine Pedicle Screw SystemAltus Partners, LLC20181—
+4K180376K2M Patient Specific RodsK2m, Inc.20182—
+4K180210CREO® Stabilization SystemGlobus Medical, Inc.201888—
+4K171421VERTICALE® Posterior Spinal Fixation System/VERTICALE® SystemSilony Medical GmbH20186—
+4K172469TiLock Modular Spinal SystemGenesys Spine20170—
+4K172808CosmoLock Pedicle Screw SystemKalitec Direct, LLC20172—
+4K172107Threshold™ V2 Pedicular Fixation System, Threshold™ Pedicular Fixation System, Fortress™…Spineology, Inc.20170—
+4K171526Zenius™, lliad™ and Kora™ Spinal Fixation SystemsMedyssey USA, Inc.20172—
+4K171838TiLock2 Spinal SystemGenesys Spine20174—
+4K170989Dymaxeon Spine SystemBack 2 Basics Direct, LLC20172—
+4K163181TRANSLACE™ Spinal Tethering SystemMedtronic Sofamor Danek USA, Inc.20172—
+4K170266Palisade™ Pedicular Fixation SystemSpineology, Inc.20172—
+4K170255Threshold™ V2 Pedicular Fixation SystemSpineology, Inc.20171—
+4K170251Threshold™ Pedicular Fixation SystemSpineology, Inc.20171—
+4K170268Fortress™ Pedicular Fixation SystemSpineology, Inc.20171—
+4K161332NILE Proximal Fixation Spinal SystemK2m, Inc.20175—
+4K163096GPC BRAND Posterior, Non cervical Pedicle Screw Spinal SystemGpc Medical Limited20170—
+4K163471Kalitec Direct InSePtion™ MIS Fixation SystemKalitec Direct, LLC20176—
+4K162760Spine Wave Anterior Cervical Spine SystemSpine Wave, Inc.20171—
+4K162750Libra Pedicle Screw SystemSpinal Balance, Inc.20160—
+4K161014NuVasive® Reline® SystemNu Vasive, Incorporated201648—
+4K162143FixxSure® X-LinkInnovasis, Inc.20160—
+4K161766PathLoc-L MIS Spinal SystemL&K BIOMED Co., Ltd.201618—
+4K161914Genesys Spine TiLock Cortical Spinal SystemGenesys Spine20161—
+4K161387Mont Blanc and Mont Blanc MIS Spinal SystemsSpineway SA20163—
+4K161369EVEREST Spinal SystemK2m, Incorporated20169—
+4K161363Arsenal Spinal Fixation SystemAlphatec Spine, Inc.201675—
+4K153404Zavation Spinal SystemZavation, LLC20161—
+4K151977icotec Pedicle SystemIcotec AG201630—
+4K160466Response 5.5 Spine SystemOrthoPediatrics Corp.20161—
+4K160208NILE Alternative Fixation Spinal SystemK2m, Inc.20165—
+4K153442CD HORIZON Spinal System, Medtronic Navigated Manual Reusable Instruments for Use with…Medtronic Sofamor Danek USA, Inc.201684—
+4K153428Firebird Spinal Fixation System, Phoenix MIS Spinal Fixation SystemOrthofix, Inc.2016731
+4K152968Arsenal Spinal Fixation SystemAlphatec Spine, Inc.201583—
+4K153031RANGE/DENALI/MESA Spinal SystemK2m, Incorporated20152—
+4K151974Polaris Spinal SystemBiomet Spine201516—
+4K152039Genesys Spine TiLock2 Spinal SystemGenesys Spine20157—
+4K152132X-spine Pedicle Screw SystemX-Spine Systems, Inc.201511
+4K150896Vitality Spinal Fixation SystemZimmer Spine, Inc.2015193
+4K151422Reform Pedicle Screw SystemPrecision Spine, Inc.201519—
+4K150856Reform Pedicle Screw SystemPrecision Spine, Inc.201526—
+4K151488Firebird Spinal Fixation System/Phoenix MIS Spinal Fixation SystemOrthofix, Inc.2015781
+4K150184Dymaxeon Spine SystemBack 2 Basics Direct, LLC201541
+4K142835Iliad Pedicle Screw System and Zenius Pedicle Screw SystemMedyssey USA, Inc.20155—
+4K150283Republic Spine Dark Star Spinal SystemRepublic Spine, LLC20154—
+4K143363VENUS Spinal Fixation SystemL&K BIOMED Co., Ltd.201533—
+4K143731IMPLANET Spine System (ISS)Implanet, S.A.20158—
+4K141222Nautilus Spinal System and Solstice Oct SystemLife Spine, Inc.201513—
+4K141253New Era Orthopaedics Polyscrew Pedicle Screw SystemNew Era Orthopaedics, LLC201511
+4K143149Arsenal Spinal Fixation SystemAlphatec Spine, Inc.201584—
+4K141186Firebird Spinal Fixation SystemOrthofix, Inc.20153—
+4K141695Acrosspine Pedicle Screw SystemArthro-Dif20140—
+4K143248Reform Pedicle Screw SystemPrecision Spine, Inc.201430—
+4K142146Ibis Pedicle Screw SystemOrtho Development Corp.20145—
+4K142185Expedium Verse Spine SystemDepuy Spine, Inc.201420—
+4K141850Flospine Pedicle Screw SystemFlospine20140—
+4K141804Polaris Spinal System - HA CoatedBiomet Spine, LLC201421—
+4K141873Range/Mesa/Denali Spinal SystemK2m, Inc.201430—
+4K140765Range/Mesa/Denali Spinal SystemK2m, Inc.201415—
+4K141147Range Spinal SystemK2m, Inc.20141—
+4K140529Everest Spinal SystemK2m, LLC201431—
+4K133221Arsenal Spinal Fixation SystemAlphatec Spine, Inc.20141502
+4K133350Revere Stabilization SystemGlobus Medical, Inc.201493—
+4K132757Everest Spinal SystemK2m, Inc.201341—
+4K131533Cayman MI Plate SystemK2m, Inc.201372—
+4K132303Implanet Spine SystemImplanet, S.A.201315—
+4K132361Everest Spinal SystemK2m, Inc.201334—
+4K131878Lliad, Kora, Zenius Pedicle Screw SystemMedyssey USA, Inc.20138—
+4K131785Pagoda Pedicle Screw SystemOrtho Development Corp.20136—
+4K131538Caplox II Pedicle Screw System/Towerlox Pedicle Screw SystemCaptiva Spine20136—
+4K124058Creo Stabilization SystemGlobus Medical, Inc.2013172—
+4K123552Instinct Java SystemZimmer Spine201301
+4K130291S4 Spinal SystemAesculap Implant System, Inc.201344—
+4K123783Ellipse Occipito-Cerico-Thoracic Spinal System and Capitol ImplantsGlobus Medical, Inc.201397—
+4K123487Gso GS1 Cannulated Screw SystemGold Standard Orthopaedics, LLC20130—
+4K123549Polaris Spinal System - Ballista II Percutaneous Screw Placement SystemBiomet Spine (Aka Ebi, LLC)2013752
+4K122592Instinct Java SystemZimmer Spine201301