510(k) Report

Devices descending from K933881

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

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+3K193219G Surgical Marksman SystemG Surgical, LLC20191—
+3K192121Black Diamond Pedicle Screw SystemOsseus Fusion Systems201913—
+3K191932Momentum™ Posterior Spinal Fixation SystemUlrich Medical USA20192—
+3K190360LineSider™ Spinal SystemIntegrity Implants, Inc.201913—
+3K182974NuVasive Reline SystemNu Vasive, Incorporated201911—
+3K180686SeaSpine Daytona Small Stature Spinal SystemSeaSpine Orthopedics Corporation201812—
+3K180433Ennovate®Aesculap Implant Systems, LLC201811
+3K180458FOCUS Pedicle Screw SystemNvision Biomedical Technologies, LLC20181—
+3K180324Patriot Spinal Fixation SystemValorus Spine20180—
+3K180176SeaSpine NewPort Spinal SystemSeaSpine Orthopedics Corporation20180—
+3K173185SEURAT™ Universal Pedicle Screw SystemCtl Medical Corporation20180—
+3K173882SeaSpine Mariner Pedicle Screw SystemSeaSpine Orthopedics Corporation2018561
+3K173508Everest Spinal SystemK2m20189—
+3K171832Range/Denali/Mesa Spinal SystemK2m, Inc.201713—
+3K171582NEO Pedicle Screw System™Neo Medical SA20170—
+3K171526Zenius™, lliad™ and Kora™ Spinal Fixation SystemsMedyssey USA, Inc.20172—
+3K161225Paonan Armstrong Posterior Spinal Fixation SystemPaonan Biotech Co., Ltd.20172—
+3K170861PremierShandong Weigao Orthopaedic Device Co., Ltd.20170—
+3K170821ChoiceSpine™ Proliant® Posterior Pedicle Screw and Hook Fixation SystemChoicespine, LP20170—
+3K163363SurgTech Thoracolumbosacral (TLS) Posterior Fixation SystemSurgtech, Inc.20170—
+3K162995Ibis® Pedicle Screw SystemOrtho Development Corporation20173—
+3K163604SeaSpine® Daytona® Small Stature Spinal SystemSeaSpine Orthopedics Corporation201712—
+3K170163Erisma® LP Spinal Fixation SystemClariance, Sas20172—
+3K162786PASS LP Spinal SystemMedicrea International SA20176—
+3K161842Overwatch Spine SystemAmendia, Inc.201661
+3K161535SeaSpine® NewPort™ Spinal SystemSeaSpine Orthopedics Corporation201614—
+3K161516G Surgical Marksman MIS SystemG Surgical, LLC20163—
+3K161028K2M Growing Spine SystemK2m, Inc.20163—
+3K152920Savannah-T® Pedicle Screw SystemAmendia, Inc.201601
+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—
+3K151849Seneka I Polyscrew Pedicle Fixation SystemSenecka Spine20151—
+3K151727Everest Spinal SystemK2m, Inc.201511—
+3K143110GALAXY MIS Screw SystemBm Korea20152—
+3K150600Response 5.5/6.0 Spine SystemOrthoPediatrics Corp.2015163
+3K150325Range/Denali/Mesa Spinal SystemK2m, Inc.201512—
+3K143350Nile Alternative FixationK2m, Inc.201510—
+3K142655CB PROT II Posterior Spinal SystemChin Bone Technique Corp20150—
+3K141291Vertiform Posterior Fixation SystemNext Orthosurgical20142—
+3K141372Mercury Spinal SystemSpinal Elements, Inc.20149—
+3K141376Inertia Pedicle Screw System, Honour Spacer System, Facet Fixx, Struxxure Anterior…Nexxt Spine, LLC2014106—
+3K140238Excella Iii-D Spinal Deformity SystemInnovasis, Inc.201432
+3K140219Picasso II Mis Spinal SystemAccel Spine20141—
+3K133944Range, Spinal System, Everest Spinal SystemK2m, Inc.201433—
+3K133746Polaris Spinal SystemBiomet Spine (Aka Ebi, LLC)2014671
+3K133066Spineselect Polyscrew Pedicle Screw SystemSpineselect, LLC20140—
+3K132884Pathfinder NXT Minimally Invasive Pedicle Screw SystemZimmer Spine, Inc.20130—
+3K132014GSB Global Spinal Balance SystemNuvasive, Inc.201382—
+3K132412Inertia Mis Pedicle Screw SystemNexxt Spine, LLC2013107—
+3K132644Lospa IS Pedicle Screw (Monoaxial & Polyaxial), Lospa IS Rod- Straight (Standard), Lospa…Corentec Co., Ltd.20130—
+3K131802Expedium, Viper. Viper 2 Spine SystemDepuy Spine, A Johnson & Johnson Company2013139—
+3K131250Tiger Spine SystemCorelink, LLC201340—
+3K131784Range Spinal SystemK2m, Inc.201334—
+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—
+3K123412Range Spinal System, Small Strature ComponentsK2m, Inc.201334—
+3K121670Medyssey Cannulated Pedicle ScrewMedyssey Co, Ltd.201311—
+3K123476Mega 5.5 Spine SystemLsk Biopartners, Inc.20135—
+3K122571Malibu Spinal System with the Daytona Deformity SystemSeaspine, Inc.201262—
+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—
+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—
+3K111448Icon (TM) Modular Pedicle Screw SystemOrthofix, Inc.20120—
+3K120140Focus Spinal SystemL&K BIOMED Co., Ltd.201225—
+3K120047Coral Spinal SystemTheken Spine, LLC201214—
+3K103573ARTS2 Spinal Fixation SystemAdvanced Medical Technologies20110—
+3K112551S4 Spinal SystemAesculap Implant System, Inc.201161—
+3K111913Capsure (R) PS SystemSpine Wave, Inc.20111—
+3K111301Instinct Java SystemZimmer Spine201131
+3K111957Polaris Spinal SystemBiomet Spine (Ebi, LLC)201176—
+3K110284Novel Iii Spinal Fixation and Adjustable Bridge SystemMedyssey Co, Ltd.201112—
+3K110321Tiger Spine SystemCorelink, LLC201183—
+3K103147Novel Iii Spinal Fixation and Adjustable Bridge SystemMedyssey Co, Ltd.201013—
+3K093926Firebird Spinal Fixation SystemBlackstone Medical, Inc.201088—
+3K093104Medyssey CO., LTD., Zenius Spinal SystemMedyssey Co, Ltd.201020—
+3K100122Modification to Capsure PS SystemSpine Wave, Inc.20102—
+3K070385TI-Tamed Spinal SystemTi-Tamed (Pty), Ltd.20090—
+3K091110Spinal Edge Titan Pedicle Screw SystemSpinal Edge, LLC20091—
+3K082353Mercury Spinal SystemSpinal Elements, Inc.200911—
+3K083230Mercury Spinal SystemSpinal Elements, Inc.200811—
+3K072605Malibu Spinal SystemSeaspine, Inc.200767—