510(k) Report

Devices descending from K955348

1,019 later devices reach Titanium Moss Miami Spinal System through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+4K220025ARx® Spinal SystemLife Spine, Inc.20220—
+4K213750VyLink™ Spinal Screw SystemVy Spine, LLC20221—
+4K211935ORIO-Ti Intervertebral Body Fusion Cage SystemSpinecraft, LLC20210—
+4K212692Mariner Pedicle Screw SystemSeaSpine Orthopedics Corporation202146—
+4K203607MOSS VRS Spinal SystemBiedermann Motech GmbH & Co. KG20210—
+4K210963ENNOVATE Spinal SystemAesculap Implant Systems, LLC20210—
+4K211606Mariner Deformity SystemSeaSpine Orthopedics Corporation2021471
+4K211323ASTRA Spine SystemSpinecraft, LLC202112—
+4K210716CarboClear X Pedicle Screw System, CarboClear X Navigated InstrumentsCarboFix Orthopedics, Ltd.20218—
+4K203317CarboClear X Pedicle Screw SystemCarboFix Orthopedics, Ltd.20209—
+4K200790LnK Spinal Fixation System, OpenLoc-L Spinal Fixation SystemL&K BIOMED Co., Ltd.20205—
+4K200937ACURA Stabilization SystemIndius Medical Technologies Pvt., Ltd.20200—
+4K200981Mega Plus MIS Spine SystemBk Meditech, Co., Ltd.20200—
+4K192930Dymaxeon Spine SystemBack 2 Basics Direct, LLC20201—
+4K200519CarboClear® II Pedicle Screw SystemCarboFix Orthopedics, Ltd.202011—
+4K193100RESPONSE™ Spine System, RESPONSE™ 4.5/5.0 Spine System, RESPONSE™ 5.5/6.0 Spine SystemOrthoPediatrics Corp.20204—
+4K200381Daytona® Small Stature Spinal SystemSeaSpine Orthopedics Corporation20202—
+4K192268Europa Pedicle Screw SystemMiRus, LLC20190—
+4K190636NuVasive® Reline® 4.5-5.0 SystemNu Vasive, Incorporated201913—
+4K191576Mercury® Spinal System, Overwatch® Spinal SystemSpinal Elements, Inc.20195—
+4K191648Mariner MIS Pedicle Screw System; SeaSpine Navigation SystemSeaSpine Orthopedics Corporation201949—
+4K191757EUROPA Pedicle Screw SystemMiRus, LLC20191—
+4K183639Mariner Outrigger Revision SystemSeaSpine Orthopedics Corporation20198—
+4K182721Choice Spine Navigation SystemChoicespine, LP20192—
+4K182239OLYMPIC Posterior Spinal Fixation SystemAstura Medical, LLC20182—
+4K182240PASS LP Spinal SystemMedicrea International SA20182—
+4K182377CarboClear® Pedicle Screw SystemCarboFix Orthopedics, Ltd.201839—
+4K181390Response Spine System, Response 5.5/6.0 Spine System, Response 4.5/5.0 Spine SystemOrthoPediatrics Corp.201813—
+4K181435ATEC Cervical Spacer SystemAlphatec Spine, Inc.2018100—
+4K181677Kodiak Spinal Fixation SystemAlphatec Spine, Inc.201870—
+4K181495Republic Spine Dark Star Spinal SystemRepublic Spine, LLC20183—
+4K173645JASPER Spinal Fixation SystemGbs Commonwealth Co., Ltd.20183—
+4K181119Range (Denali and Mesa) Spinal SystemsK2m, Inc.20185—
+4K181281Altus Spine Pedicle Screw SystemAltus Partners, LLC20181—
+4K180433Ennovate®Aesculap Implant Systems, LLC201811
+4K172967Mercury® Spinal SystemSpinal Elements, Inc.20185—
+4K180376K2M Patient Specific RodsK2m, Inc.20182—
+4K180210CREO® Stabilization SystemGlobus Medical, Inc.201888—
+4K172269FORTRESS™ Radiopaque Bone Cement (FORTRESS™ and FORTRESS-Plus™), CREO® Fenestrated Screw…Globus Medical, Inc.20184—
+4K173185SEURAT™ Universal Pedicle Screw SystemCtl Medical Corporation20180—
+4K171497Mikron Spinal Fixation SystemMikron Makina Sanayi Ticaret Co., Ltd.20174—
+4K171832Range/Denali/Mesa Spinal SystemK2m, Inc.201713—
+4K171526Zenius™, lliad™ and Kora™ Spinal Fixation SystemsMedyssey USA, Inc.20172—
+4K171456Thunderbolt™ Minimally Invasive and Lancer™ Open Pedicle Screw SystemsChoicespine20170—
+4K170942The Thunderbolt™ Minimally Invasive and Lancer™ Open Pedicle Screw SystemsChoicespine, LP20170—
+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—
+4K170126NuVasive® Reline® 4.5-5.0 SystemNu Vasive, Incorporated201739—
+4K162066Reliance Spinal Screw SystemReliance Medical Systems, LLC20163—
+4K162160Preference Elite Pedicle Screw SystemAmedica Corporation20161—
+4K162750Libra Pedicle Screw SystemSpinal Balance, Inc.20160—
+4K162367Erisma® LP MISClariance, Sas20162—
+4K162143FixxSure® X-LinkInnovasis, Inc.20160—
+4K161499VertiForm Posterior Fixation SystemNext Orthosurgical20161—
+4K161028K2M Growing Spine SystemK2m, Inc.20163—
+4K161369EVEREST Spinal SystemK2m, Incorporated20169—
+4K160989NuVasive® Reline® SystemNu Vasive, Incorporated201667—
+4K160775Thunderbolt™ Minimally Invasive and Lancer™ Open Pedicle Screw SystemsChoicespine, LP201673—
+4K160466Response 5.5 Spine SystemOrthoPediatrics Corp.20161—
+4K150918PASS OCT Spinal SystemMedicrea International SA201513—
+4K152131Reliance Spinal Screw SystemReliance Medical Systems, LLC20154—
+4K150380ProMIS Fixation SystemPremia Spine, Ltd.20154—
+4K151196Nautilus Spinal SystemLife Spine, Inc.201512—
+4K142835Iliad Pedicle Screw System and Zenius Pedicle Screw SystemMedyssey USA, Inc.20155—
+4K151215Mercury Spinal SystemSpinal Elements, Inc.20158—
+4K143684NuVasive Reline SystemNu Vasive, Incorporated201577—
+4K143363VENUS Spinal Fixation SystemL&K BIOMED Co., Ltd.201533—
+4K143200MIS Z-Pedicle Screw SystemZ-Medical GmbH & Co. KG201514—
+4K141253New Era Orthopaedics Polyscrew Pedicle Screw SystemNew Era Orthopaedics, LLC201511
+4K142737MAS PLIF Fixation systemNu Vasive, Incorporated20141—
+4K142185Expedium Verse Spine SystemDepuy Spine, Inc.201420—
+4K142499Reline SystemNu Vasive, Incorporated201478—
+4K141804Polaris Spinal System - HA CoatedBiomet Spine, LLC201421—
+4K141873Range/Mesa/Denali Spinal SystemK2m, Inc.201430—
+4K140765Range/Mesa/Denali Spinal SystemK2m, Inc.201415—
+4K140678Cosmolock Pedicle Screw SystemKalitec Direct, LLC201410—
+4K141147Range Spinal SystemK2m, Inc.20141—
+4K140529Everest Spinal SystemK2m, LLC201431—
+4K140696Streamline TL Spinal Fixation SystemPioneer Surgical Technology, Inc.20145—
+4K133944Range, Spinal System, Everest Spinal SystemK2m, Inc.201433—
+4K133350Revere Stabilization SystemGlobus Medical, Inc.201493—
+4K132403Annextm Adjacent Level SystemSpine Wave, Inc.20142—
+4K132757Everest Spinal SystemK2m, Inc.201341—
+4K131533Cayman MI Plate SystemK2m, Inc.201372—
+4K132280Altus Spine Pedicle Screw SystemAltus Partners20136—
+4K131784Range Spinal SystemK2m, Inc.201334—
+4K131810Osseus Black Diamond Pedicle Screw SystemOsseus Fusion Systems, LLC201314—
+4K130932Firebird Spinal Fixation SystemOrthofix, Inc.2013811
+4K124058Creo Stabilization SystemGlobus Medical, Inc.2013172—
+4K131030Range Spinal SystemK2m, Inc.201334—
+4K122877Range Spinal System, Small StatureK2m, Inc.201334—
+4K130330Range Spinal SystemK2m, Inc.201336—
+4K123552Instinct Java SystemZimmer Spine201301
+4K123783Ellipse Occipito-Cerico-Thoracic Spinal System and Capitol ImplantsGlobus Medical, Inc.201397—
+4K123549Polaris Spinal System - Ballista II Percutaneous Screw Placement SystemBiomet Spine (Aka Ebi, LLC)2013752
+4K123623Illico Mis Posterior Fixation SystemAlphatec Spine, Inc.201321
+4K123412Range Spinal System, Small Strature ComponentsK2m, Inc.201334—
+4K123521Reliance Spinal Screw SystemReliance Medical Systems, LLC20135—