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
+3K173508Everest Spinal SystemK2m20189—
+3K171497Mikron Spinal Fixation SystemMikron Makina Sanayi Ticaret Co., Ltd.20174—
+3K171832Range/Denali/Mesa Spinal SystemK2m, Inc.201713—
+3K171582NEO Pedicle Screw System™Neo Medical SA20170—
+3K170861PremierShandong Weigao Orthopaedic Device Co., Ltd.20170—
+3K170821ChoiceSpine™ Proliant® Posterior Pedicle Screw and Hook Fixation SystemChoicespine, LP20170—
+3K162995Ibis® Pedicle Screw SystemOrtho Development Corporation20173—
+3K163604SeaSpine® Daytona® Small Stature Spinal SystemSeaSpine Orthopedics Corporation201712—
+3K170163Erisma® LP Spinal Fixation SystemClariance, Sas20172—
+3K170061ProMIS™ Fixation SystemPremia Spine, Ltd.20170—
+3K162786PASS LP Spinal SystemMedicrea International SA20176—
+3K162066Reliance Spinal Screw SystemReliance Medical Systems, LLC20163—
+3K161842Overwatch Spine SystemAmendia, Inc.201661
+3K161535SeaSpine® NewPort™ Spinal SystemSeaSpine Orthopedics Corporation201614—
+3K161499VertiForm Posterior Fixation SystemNext Orthosurgical20161—
+3K161028K2M Growing Spine SystemK2m, Inc.20163—
+3K152920Savannah-T® Pedicle Screw SystemAmendia, Inc.201601
+3K160989NuVasive® Reline® SystemNu Vasive, Incorporated201667—
+3K160902Mariner Pedicle Screw SystemSeaSpine Orthopedics Corporation201660—
+3K153453Inertia Pedicle Screw and Deformity Correxxion SystemNexxt Spine, LLC201617—
+3K151704Diplomat® Spinal SystemSignus Medizintechnik GmbH20164—
+3K153525Seneka II Polyscrew Pedicle Fixation SystemSenecka Spine20160—
+3K151770Libra Pedicle Screw SystemSpinal Balance, Inc.20151—
+3K151648Altus Spine Pedicle Screw System, Altus Spine MIS Pedicle Screw System, Valencia Pedicle…Altus Partners, LLC20155—
+3K152131Reliance Spinal Screw SystemReliance Medical Systems, LLC20154—
+3K151727Everest Spinal SystemK2m, Inc.201511—
+3K143110GALAXY MIS Screw SystemBm Korea20152—
+3K151215Mercury Spinal SystemSpinal Elements, Inc.20158—
+3K150600Response 5.5/6.0 Spine SystemOrthoPediatrics Corp.2015163
+3K143684NuVasive Reline SystemNu Vasive, Incorporated201577—
+3K150325Range/Denali/Mesa Spinal SystemK2m, Inc.201512—
+3K143350Nile Alternative FixationK2m, Inc.201510—
+3K142655CB PROT II Posterior Spinal SystemChin Bone Technique Corp20150—
+3K142737MAS PLIF Fixation systemNu Vasive, Incorporated20141—
+3K142499Reline SystemNu Vasive, Incorporated201478—
+3K141376Inertia Pedicle Screw System, Honour Spacer System, Facet Fixx, Struxxure Anterior…Nexxt Spine, LLC2014106—
+3K140678Cosmolock Pedicle Screw SystemKalitec Direct, LLC201410—
+3K140238Excella Iii-D Spinal Deformity SystemInnovasis, Inc.201432
+3K140219Picasso II Mis Spinal SystemAccel Spine20141—
+3K140696Streamline TL Spinal Fixation SystemPioneer Surgical Technology, Inc.20145—
+3K133944Range, Spinal System, Everest Spinal SystemK2m, Inc.201433—
+3K133746Polaris Spinal SystemBiomet Spine (Aka Ebi, LLC)2014671
+3K132403Annextm Adjacent Level SystemSpine Wave, Inc.20142—
+3K132884Pathfinder NXT Minimally Invasive Pedicle Screw SystemZimmer Spine, Inc.20130—
+3K132280Altus Spine Pedicle Screw SystemAltus Partners20136—
+3K132412Inertia Mis Pedicle Screw SystemNexxt Spine, LLC2013107—
+3K131802Expedium, Viper. Viper 2 Spine SystemDepuy Spine, A Johnson & Johnson Company2013139—
+3K131784Range Spinal SystemK2m, Inc.201334—
+3K130932Firebird Spinal Fixation SystemOrthofix, Inc.2013811
+3K131343Reform Pedicle Screw SystemSpinal USA201331—
+3K130279Reform Pedicle Screw SystemSpinal USA201331—
+3K131030Range Spinal SystemK2m, Inc.201334—
+3K130655Response Spine SystemOrthoPediatrics Corp.201317—
+3K130330Range Spinal SystemK2m, Inc.201336—
+3K123939S4 Spinal SystemAesculap Implant Systems, Inc.20133—
+3K123623Illico Mis Posterior Fixation SystemAlphatec Spine, Inc.201321
+3K123412Range Spinal System, Small Strature ComponentsK2m, Inc.201334—
+3K123521Reliance Spinal Screw SystemReliance Medical Systems, LLC20135—
+3K121670Medyssey Cannulated Pedicle ScrewMedyssey Co, Ltd.201311—
+3K122571Malibu Spinal System with the Daytona Deformity SystemSeaspine, Inc.201262—
+3K122814Galleon Pedicle Screw SystemEverest Spine, LLC20120—
+3K123451Polaris Spinal System - Ballista II RodsBiomet Spine (Aka Ebi, LLC)20120—
+3K121786Dymaxeon Spine SystemB2b Spine Pty, Ltd.20125—
+3K122226Revere Stabilization SystemGlobus Medical, Inc.2012225—
+3K120891Tangors Multifunctional Posterior SystemUlrich GmbH & Co. KG201218—
+3K121568Dali Spinal Fixation SystemAccel Spine20121—
+3K121630Range Spinal SystemK2m, Inc.2012127—
+3K122145Lanx Spinal Fixation SystemLanx, Inc.201271
+3K120838Synthes Matrix SystemSynthes Spine201216—
+3K121671Pathfinder NXT Minimally Invasive Pedicle Screw SystemZimmer Spine, Inc.20120—
+3K120564Calypso SystemHogan Lovells US LLP201216—
+3K121250OP Spine SystemOrthoPediatrics Corp.201218—
+3K120646Capsure (R) PS SystemSpine Wave, Inc.20120—
+3K120928Synthes Matrix SystemSynthes Spine20120—
+3K120571Synthes Uss ConnectorSynthes Spine201274—
+3K121020Viper SystemDepuy Spine, Inc.201294—
+3K113058Tiger Spine SystemCorelink, LLC201281—
+3K120270Venus Spinal Fixation SystemL&K BIOMED Co., Ltd.2012111—
+3K120140Focus Spinal SystemL&K BIOMED Co., Ltd.201225—
+3K113396Depuy Pulse Thoracolumbar Screw SystemMedos International SARL20121—
+3K120047Coral Spinal SystemTheken Spine, LLC201214—
+3K111634Xenon (TM) Pedicle Screw SystemAlphatec Spine, Inc.20120—
+3K103573ARTS2 Spinal Fixation SystemAdvanced Medical Technologies20110—
+3K112920Range Spinal System (Mesa and Denali)K2m, Inc.201149—
+3K112551S4 Spinal SystemAesculap Implant System, Inc.201161—
+3K111301Instinct Java SystemZimmer Spine201131
+3K111957Polaris Spinal SystemBiomet Spine (Ebi, LLC)201176—
+3K110321Tiger Spine SystemCorelink, LLC201183—
+3K101353Golden Gate Anterior Plate SystemUlrich GmbH & Co. KG20110—
+3K102249Expedium Spine SystemDepuy Spine, A Johnson & Johnson Company2010218—
+3K102488Apex Spine System W/ Cocr RodsSpinecraft, LLC2010177—
+3K102204Choice Spine Starfire Pedicle Screw SystemChoicespine, LP201088—
+3K102248Excella II Spinal System Model EC2-00Innovasis, Inc.201043
+3K100757Tilock Pedicle Screw SystemGenesys Spine201091
+3K100685Zodiac Polyaxial Spinal Fixation SystemAlphatec Spine, Inc.2010168—
+3K100138Zodiac Polyaxial Spinal Fixation SystemAlphatec Spine, Inc.20100—
+3K093077Zodiac Polyaxial Spinal Fixation SystemAlphatec Spine, Inc.2009170—
+3K083567Gii Spinal Fixation System, Gii-TI-Poly Axial ScrewCo-Ligne AG20091—
+3K091189Zodiac Polyaxial Spinal Fixation SystemAlphatec Spine, Inc.20093—
+3K090779Zodiac Polyaxial Spinal Fixation SystemAlphatec Spine, Inc.20090—