510(k) Report

Devices descending from K953915

765 later devices reach Moss Miami Spinal System (Anterior Use) through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+3K091445CD Horizon Spinal SystemMedtronic Sofamor Danek2010581—
+3K100685Zodiac Polyaxial Spinal Fixation SystemAlphatec Spine, Inc.2010168—
+3K100138Zodiac Polyaxial Spinal Fixation SystemAlphatec Spine, Inc.20100—
+3K093077Zodiac Polyaxial Spinal Fixation SystemAlphatec Spine, Inc.2009170—
+3K091189Zodiac Polyaxial Spinal Fixation SystemAlphatec Spine, Inc.20093—
+3K090779Zodiac Polyaxial Spinal Fixation SystemAlphatec Spine, Inc.20090—
+3K091587Mercury Spinal SystemSpinal Elements, Inc.200910—
+3K081158Zodic Polyaxial Spinal Fixation SystemAlphatec Spine, Inc.20080—
+3K081597Modification to Vertebron PSS Pedicle Screw SystemVertebron, Inc.200822—
+3K081228Capsure PS (R) Spine SystemSpine Wave, Inc.200839—
+3K073143Modified Vertiflex Spinal Screw SystemVertiflex, Inc.20080—
+3K073531Accin Pedicle Screw SystemAccelerated Innovation, LLC20080—
+3K072685Ngarde SystemN Spine, Inc.200709
+3K071376Modification to Vertebron PSS Pedicle Screw SystemVertebron, Inc.200749—
+3K051716Vertebron PSS Pedicle Screw SystemVertebron, Inc.200556—
+3K043152Vertebron PSS Pedicle Screw SystemVertebron, Inc.200561—
+4K262828KHEIRON® Spinal Fixation System, including patient specific K-RODS.M.A.I.O20260—
+4K252542LEO Spinal SystemZheJiang Decans Medical Devices Co., Ltd.20260—
+4K253940M.U.S.T. Pedicle Screw System - ExtensionMedacta International S.A.20260—
+4K260786KHEIRON® Spinal Fixation System, including patient specific K-RODS.M.A.I.O20261—
+4K252322SIros-X SystemGenesys Spine20250—
+4K251719Momentum® Posterior Spinal Fixation SystemUlrich Medical USA, Inc.20250—
+4K251131Annex® 2 Adjacent Level SystemSpine Wave, Inc.20250—
+4K243916Primus Spinal Fixation SystemSpinal Elements, Inc.20252—
+4K242361OZARK Cervical Plate System; PYRENEES® Cervical Plate System; EVEREST® Spinal System…Stryker Spine20241—
+4K241657MSFX Mikron Spinal Fixation SystemMikron Makina Sanayi VE Ticaret Ltd. Sti.20243—
+4K240233Pitkar Spinal Pedicle Screw SystemS.H.Pitkar Orthotools Pvt., Ltd.20240—
+4K240180Orthopeasia Spinal Fixation SystemOrthopeasia Co., Ltd.20240—
+4K241519Invictus® Small Stature Spinal Fixation SystemAlphatec Spine, Inc.20242—
+4K240846CarboClear® Hybrid Pedicle Screw System; CarboClear® Hybrid Navigated Instruments…CarboFix Orthopedics, Ltd.20242—
+4K233951CD Horizon ModuLeX Spinal System (Shanks, Head Assemblies, and Set Screw)Medtronic Sofamor Danek USA, Inc.20245—
+4K233508iFuse Bedrock Granite® Implant SystemSI-BONE, Inc.20245—
+4K232572Kalitec Navigated Instrument SystemKalitec Direct, LLC Doing Business AS Kalitec Medical20230—
+4K231443Mini-OSTEO Pedicle Fixation SystemOsteomed Indústria E Comércio DE Implantes Ltda20230—
+4K232719ProMIS Extension Rod SystemPremia Spine, Ltd.20230—
+4K232561Ripley Spinal Screw System by SAGICOSagico VA USA, LLC20230—
+4K231744VyLink™ Spinal Screw SystemVy Spine, LLC20230—
+4K232650KHEIRON® Spinal Fixation System, including patient specific K-RODS.M.A.I.O20236—
+4K230974NIDO™ Pedicle Screw SystemKalitec Medical20230—
+4K223301ASTRA & AVANT Navigation Instruments System and ASTRA-OCT Navigation Instruments SystemSpinecraft, LLC20230—
+4K231799INERTIA® CONNEXX™ Modular Pedicle Screw SystemNexxt Spine, LLC20230—
+4K230766Altus Spine Monaco Pedicle Screw SystemAltus Spine20231—
+4K221776NextGen Pedicle Screw SystemCorelink, LLC20222—
+4K221332OsteoCentric Spine MIS Pedicle Fastener SystemOsteoCentric Technologies20221—
+4K221244CD Horizon™ Spinal SystemMedtronic202220—
+4K213491Universal Pilot Guidance Instrument SystemCtl Medical Corporation20220—
+4K213935PISCES-SA Standalone ALIF Interbody SystemOsseus Fusion Systems202212—
+4K220038Camber Spine Navigation SystemCamber Spine Technologies20220—
+4K212489BonOs Inject Bone Cement; NEO Pedicle Screw SystemNeo Medical SA20215—
+4K210963ENNOVATE Spinal SystemAesculap Implant Systems, LLC20210—
+4K210874Reliance Spinal Screw SystemReliance Medical Systems, LLC20212—
+4K210539CoreLink Midline Fixation SystemCorelink, LLC20214—
+4K210716CarboClear X Pedicle Screw System, CarboClear X Navigated InstrumentsCarboFix Orthopedics, Ltd.20218—
+4K203056Invictus™ Spinal Fixation SystemAlphatec Spine, Inc.202061—
+4K200937ACURA Stabilization SystemIndius Medical Technologies Pvt., Ltd.20200—
+4K202327Invictus™ OsseoScrew® SystemAlphatec Spine, Inc.20200—
+4K200596G21 Cement, VADER® Pedicle SystemIcotec AG2020271
+4K200981Mega Plus MIS Spine SystemBk Meditech, Co., Ltd.20200—
+4K201251CarboClear Navigated InstrumentsCarboFix Orthopedics, Ltd.20209—
+4K193423VADER®one Pedicle System MIS and LightMore® Pedicle System 6.0Icotec AG202061
+4K193100RESPONSE™ Spine System, RESPONSE™ 4.5/5.0 Spine System, RESPONSE™ 5.5/6.0 Spine SystemOrthoPediatrics Corp.20204—
+4K193472OrthoCircle Spine Pedicle Screw SystemOrthocircle Spine20200—
+4K193270CapLOX II®/TowerLOX® MIS Pedicle Screw SystemCaptiva Spine, Inc.20200—
+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—
+4K190636NuVasive® Reline® 4.5-5.0 SystemNu Vasive, Incorporated201913—
+4K191854Premia Spine XL InstrumentsPremia Spine, Ltd.20190—
+4K191726mont blanc & mont blanc MIS Spinal SystemsSpineway SA20190—
+4K190360LineSider™ Spinal SystemIntegrity Implants, Inc.201913—
+4K190545VADER® one Pedicle System MIS and LightMore® Pedicle System 6.0Icotec AG2019291
+4K182974NuVasive Reline SystemNu Vasive, Incorporated201911—
+4K183080Mega Plus Spine SystemBk Meditech, Co., Ltd.20182—
+4K180498NuVasive Reline Fenestrated Screws, High V+ Bone CementNu Vasive, Incorporated201841—
+4K182239OLYMPIC Posterior Spinal Fixation SystemAstura Medical, LLC20182—
+4K182240PASS LP Spinal SystemMedicrea International SA20182—
+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—
+4K181339Altus Spine Pedicle Screw SystemAltus Partners, LLC20186—
+4K181139OLYMPIC Posterior Spinal Fixation SystemAstura Medical, LLC20188—
+4K181119Range (Denali and Mesa) Spinal SystemsK2m, Inc.20185—
+4K181281Altus Spine Pedicle Screw SystemAltus Partners, LLC20181—
+4K180220SAGICO OSI Spinal System by OsimplantSpinal Analytics & Geometrical Implant Co, LLC20181—
+4K180376K2M Patient Specific RodsK2m, Inc.20182—
+4K180210CREO® Stabilization SystemGlobus Medical, Inc.201888—
+4K180475CapLOX II® / TowerLOX® MIS Pedicle Screw SystemCaptiva Spine, Inc.20180—
+4K173180Mega Plus Spine SystemBk Meditech, Co., Ltd.20183—
+4K172115Navigated Instrument SystemOrthofix, Inc.20184—
+4K171421VERTICALE® Posterior Spinal Fixation System/VERTICALE® SystemSilony Medical GmbH20186—
+4K172469TiLock Modular Spinal SystemGenesys Spine20170—
+4K172808CosmoLock Pedicle Screw SystemKalitec Direct, LLC20172—
+4K171832Range/Denali/Mesa Spinal SystemK2m, Inc.201713—
+4K171582NEO Pedicle Screw System™Neo Medical SA20170—
+4K163096GPC BRAND Posterior, Non cervical Pedicle Screw Spinal SystemGpc Medical Limited20170—
+4K163471Kalitec Direct InSePtion™ MIS Fixation SystemKalitec Direct, LLC20176—
+4K162921Navigated Instrument SystemOrthofix, Inc.20175—
+4K162760Spine Wave Anterior Cervical Spine SystemSpine Wave, Inc.20171—
+4K170163Erisma® LP Spinal Fixation SystemClariance, Sas20172—
+4K161014NuVasive® Reline® SystemNu Vasive, Incorporated201648—