510(k) Report

Devices descending from K982320

538 later devices reach Depuy Motech Moss Miami Spinal System through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K202327Invictus™ OsseoScrew® SystemAlphatec Spine, Inc.20200—
+1K191212CrossOver Cross Connectors, DePuy PULSE Thoracolumbar Screw System, EXPEDIUM Fenestrated…Medos International SARL20190—
+1K160926F1 MPS Modular Pedicle Screw SystemDegen Medical20161—
+1K061321Zodiac Adjustable Bridges, Models 11-20XX,11-25XX,11-30XX,11-35XXAlphatec Spine, Inc.20060—
+1K033090Icon Polyaxial Pedicle Screw SystemAlphatec Mfg., Inc.20041801
+1K030383Modification to Moss Miami Spinal System Polyaxial ScrewsDepuyacromed2003410—
+1K023498Modification to Blackstone Spinal Fixation SystemBlackstone Medical, Inc.2002300—
+1K020674Blackstone Spinal Fixation System 4.5MM Multi-Axial ScrewBlackstone Medical, Inc.2002305—
+1K013558Blackstone Spinal Fixation System 4.5MM Mono-Axial ScrewBlackstone Medical, Inc.2002304—
+2K2316554CIS® Chiron Spinal Fixation SystemSolco Biomedical Co., Ltd.20240—
+2K190981NEX-D2 Posterior Fixation SystemNext Orthosurgical20200—
+2K173814DeGen Medical E3 MIS Pedicle Screw SystemDegen Medical20180—
+2K161225Paonan Armstrong Posterior Spinal Fixation SystemPaonan Biotech Co., Ltd.20172—
+2K160775Thunderbolt™ Minimally Invasive and Lancer™ Open Pedicle Screw SystemsChoicespine, LP201673—
+2K153428Firebird Spinal Fixation System, Phoenix MIS Spinal Fixation SystemOrthofix, Inc.2016731
+2K141291Vertiform Posterior Fixation SystemNext Orthosurgical20142—
+2K141372Mercury Spinal SystemSpinal Elements, Inc.20149—
+2K140260Skyhawk Lateral Plate SystemOrthofix, Inc.201414—
+2K140678Cosmolock Pedicle Screw SystemKalitec Direct, LLC201410—
+2K132014GSB Global Spinal Balance SystemNuvasive, Inc.201382—
+2K123623Illico Mis Posterior Fixation SystemAlphatec Spine, Inc.201321
+2K123476Mega 5.5 Spine SystemLsk Biopartners, Inc.20135—
+2K120291OP Spine SystemOrthoPediatrics Corp.2012138—
+2K111448Icon (TM) Modular Pedicle Screw SystemOrthofix, Inc.20120—
+2K110896Reliance Spinal Screw SystemReliance Medical Systems, LLC20125—
+2K101112Reliance Spinal Screw SystemReliance Medical Systems20107—
+2K093926Firebird Spinal Fixation SystemBlackstone Medical, Inc.201088—
+2K100685Zodiac Polyaxial Spinal Fixation SystemAlphatec Spine, Inc.2010168—
+2K100138Zodiac Polyaxial Spinal Fixation SystemAlphatec Spine, Inc.20100—
+2K093077Zodiac Polyaxial Spinal Fixation SystemAlphatec Spine, Inc.2009170—
+2K091110Spinal Edge Titan Pedicle Screw SystemSpinal Edge, LLC20091—
+2K091189Zodiac Polyaxial Spinal Fixation SystemAlphatec Spine, Inc.20093—
+2K090779Zodiac Polyaxial Spinal Fixation SystemAlphatec Spine, Inc.20090—
+2K081978Reliance Spinal Screw SystemReliance Medical Systems, LLC20098—
+2K082353Mercury Spinal SystemSpinal Elements, Inc.200911—
+2K083230Mercury Spinal SystemSpinal Elements, Inc.200811—
+2K081684Blackstone Pedicle Screw SystemBlackstone Medical, Inc.20082773
+2K081158Zodic Polyaxial Spinal Fixation SystemAlphatec Spine, Inc.20080—
+2K080407Blackstone SFS Parallel Rod ConnectorsBlackstone Medical, Inc.20082961
+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—
+2K061774Nfix II Pedicle Screw SystemN Spine, Inc.200627
+2K051286Zodiac Spinal Fixation SystemAlphatec/Nexmed2005176—
+2K042514Modification to Blackstone Modular Pedicle Screw SystemBlackstone Medical, Inc.200412
+2K033352Vertebron PSS Pedicle Screw SystemVertebron, Inc.200462—
+2K030581Blackstone Spinal Fixation System Lateral Offset (System Modification)Blackstone Medical, Inc.2003298—
+2K030241Modification to Blackstone Spinal Fixation SystemBlackstone Medical, Inc.2003297—
+2K022605Blackstone Spinal Fixation System Staple & WasherBlackstone Medical, Inc.2002302—
+2K022399Blackstone Spinal Fixation System SpacerBlackstone Medical, Inc.2002300—
+3K253739SCRIPT™ Rods, CREO™ Stabilization System, REVERE® Stabilization System, REVERE® 4.5…Globus Medical, Inc.20260—
+3K250908Virata Spinal Fixation SystemSeaSpine Orthopedics Corporation202521
+3K232572Kalitec Navigated Instrument SystemKalitec Direct, LLC Doing Business AS Kalitec Medical20230—
+3K230974NIDO™ Pedicle Screw SystemKalitec Medical20230—
+3K223181NuVasive Reline SystemNu Vasive, Incorporated202311—
+3K222516Mercury® II Spinal SystemSpinal Elements, Inc.20223—
+3K211027Altus Spine Pedicle Screw SystemAltus Partners, LLC20222—
+3K213750VyLink™ Spinal Screw SystemVy Spine, LLC20221—
+3K203607MOSS VRS Spinal SystemBiedermann Motech GmbH & Co. KG20210—
+3K211710Ascent POCT System, Centurion POCT System, Spinal Fixation System (SFS), Firebird Spinal…Orthofix, Inc.20212—
+3K191576Mercury® Spinal System, Overwatch® Spinal SystemSpinal Elements, Inc.20195—
+3K181980OsseoScrew SystemAlphatec Spine, Inc.20181—
+3K181677Kodiak Spinal Fixation SystemAlphatec Spine, Inc.201870—
+3K180226TREND II Spinal Fixation System- STEP SeriesPaonan Biotech Co., Ltd.20181—
+3K172967Mercury® Spinal SystemSpinal Elements, Inc.20185—
+3K172115Navigated Instrument SystemOrthofix, Inc.20184—
+3K172808CosmoLock Pedicle Screw SystemKalitec Direct, LLC20172—
+3K171497Mikron Spinal Fixation SystemMikron Makina Sanayi Ticaret Co., Ltd.20174—
+3K1721312 Hole Lateral Plating SystemLife Spine, Inc.201710—
+3K171456Thunderbolt™ Minimally Invasive and Lancer™ Open Pedicle Screw SystemsChoicespine20170—
+3K170647Connector SystemOrthofix, Inc.201718—
+3K171082Firebird Spinal Fixation System, Phoenix MIS Spinal Fixation System, JANUS Midline…Orthofix, Inc.2017611
+3K170942The Thunderbolt™ Minimally Invasive and Lancer™ Open Pedicle Screw SystemsChoicespine, LP20170—
+3K163096GPC BRAND Posterior, Non cervical Pedicle Screw Spinal SystemGpc Medical Limited20170—
+3K163471Kalitec Direct InSePtion™ MIS Fixation SystemKalitec Direct, LLC20176—
+3K170126NuVasive® Reline® 4.5-5.0 SystemNu Vasive, Incorporated201739—
+3K162066Reliance Spinal Screw SystemReliance Medical Systems, LLC20163—
+3K161516G Surgical Marksman MIS SystemG Surgical, LLC20163—
+3K161499VertiForm Posterior Fixation SystemNext Orthosurgical20161—
+3K161363Arsenal Spinal Fixation SystemAlphatec Spine, Inc.201675—
+3K160989NuVasive® Reline® SystemNu Vasive, Incorporated201667—
+3K160362Z-Span Plate SystemZavation, LLC20163—
+3K152968Arsenal Spinal Fixation SystemAlphatec Spine, Inc.201583—
+3K151648Altus Spine Pedicle Screw System, Altus Spine MIS Pedicle Screw System, Valencia Pedicle…Altus Partners, LLC20155—
+3K152131Reliance Spinal Screw SystemReliance Medical Systems, LLC20154—
+3K150184Dymaxeon Spine SystemBack 2 Basics Direct, LLC201541
+3K151215Mercury Spinal SystemSpinal Elements, Inc.20158—
+3K150600Response 5.5/6.0 Spine SystemOrthoPediatrics Corp.2015163
+3K143684NuVasive Reline SystemNu Vasive, Incorporated201577—
+3K143149Arsenal Spinal Fixation SystemAlphatec Spine, Inc.201584—
+3K142737MAS PLIF Fixation systemNu Vasive, Incorporated20141—
+3K142499Reline SystemNu Vasive, Incorporated201478—
+3K133575Spinevision Lumis Cannulated Pedicle Screw Fixation System, Spinevision U.L.I.S. Pedicle…Spinevision S.A.20143—
+3K140696Streamline TL Spinal Fixation SystemPioneer Surgical Technology, Inc.20145—
+3K133221Arsenal Spinal Fixation SystemAlphatec Spine, Inc.20141502
+3K132403Annextm Adjacent Level SystemSpine Wave, Inc.20142—
+3K132280Altus Spine Pedicle Screw SystemAltus Partners20136—
+3K131810Osseus Black Diamond Pedicle Screw SystemOsseus Fusion Systems, LLC201314—
+3K130932Firebird Spinal Fixation SystemOrthofix, Inc.2013811