510(k) Report

Devices descending from K950697

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

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+8K243802aprevo® anterior and lateral lumbar interbody fusion device, aprevo® anterior lumbar…Carlsmed, Inc.20253—
+8K243908Tiger 2 SystemZavation Medical Products, LLC20251—
+8K242260aprevo® Cervical ACDF; aprevo® Cervical ACDF-X; aprevo® Cervical ACDF-X NO CAMCarlsmed, Inc.20243—
+8K242364IdentiTi™ II Interbody SystemAlphatec Spine, Inc.20244—
+8K242042TriALTIS™ Spine SystemMedos International SARL20241—
+8K232628VADER® Pedicle SystemIcotec AG20241—
+8K232432E3D™-A Interbody SystemEvolution Spine20248—
+8K230762EDEN Spinal Fixation MIS SystemJmt Co., Ltd.20230—
+8K223513UniVy™ OsteoVy™-Ti Cervical IBF SystemVy Spine, LLC20231—
+8K222973IdentiTi and Transcend Interbody Systems: IndentiTi Cervical Porous Ti Interbody System…Alphatec Spine, Inc.202213—
+8K222028IdentiTi™ Porous Ti Interbody System, IdentiTi™ NanoTec™ Interbody System, Transcend™…Alphatec Spine202228—
+8K221388NuVasive Reline Cervical SystemNu Vasive, Incorporated20220—
+8K220195iFuse Bedrock Granite™ Implant SystemSI-BONE, Inc.202232—
+8K211238SpineJack Expansion Kit, Vertaplex Radiopaque Bone Cement, Vertaplex HV Radiopaque Bone…Stryker Instruments20212—
+8K203319SYMPHONY™ OCT SystemMedos International SARL20211—
+8K192680Percusys® Plus Pedicle Screw SystemJoimax GmbH20190—
+8K191810Curiteva Pedicle Screw SystemCuriteva, Inc.20190—
+8K183117PathLoc-L MIS Spinal SystemL&K BIOMED Co., Ltd.20184—
+8K180210CREO® Stabilization SystemGlobus Medical, Inc.201888—
+8K171582NEO Pedicle Screw System™Neo Medical SA20170—
+8K171838TiLock2 Spinal SystemGenesys Spine20174—
+8K171807ES2 Neuromonitoring Accessory InstrumentsStryker Corporation20177—
+8K163181TRANSLACE™ Spinal Tethering SystemMedtronic Sofamor Danek USA, Inc.20172—
+8K161332NILE Proximal Fixation Spinal SystemK2m, Inc.20175—
+8K162995Ibis® Pedicle Screw SystemOrtho Development Corporation20173—
+8K160003Sniper (R) Spine SystemSpine Wave, Inc.20167—
+8K153442CD HORIZON Spinal System, Medtronic Navigated Manual Reusable Instruments for Use with…Medtronic Sofamor Danek USA, Inc.201684—
+8K152781Adena-Zina SystemShanghai Sanyou Medical Co, Ltd.20165—
+8K152132X-spine Pedicle Screw SystemX-Spine Systems, Inc.201511
+8K142438Nerve Monitoring Cable SystemPioneer Surgical Technology, Inc. (Rti Surgical, Inc.)20154—
+8K133743Baxano Surgical Mis Spinal SystemBaxano Surgical, Inc.20140—
+8K132884Pathfinder NXT Minimally Invasive Pedicle Screw SystemZimmer Spine, Inc.20130—
+8K132760Nautilus Spinal SystemLife Spine, Inc.201314—
+8K131802Expedium, Viper. Viper 2 Spine SystemDepuy Spine, A Johnson & Johnson Company2013139—
+8K131538Caplox II Pedicle Screw System/Towerlox Pedicle Screw SystemCaptiva Spine20136—
+8K124058Creo Stabilization SystemGlobus Medical, Inc.2013172—
+8K123783Ellipse Occipito-Cerico-Thoracic Spinal System and Capitol ImplantsGlobus Medical, Inc.201397—
+8K123487Gso GS1 Cannulated Screw SystemGold Standard Orthopaedics, LLC20130—
+8K123451Polaris Spinal System - Ballista II RodsBiomet Spine (Aka Ebi, LLC)20120—
+8K121671Pathfinder NXT Minimally Invasive Pedicle Screw SystemZimmer Spine, Inc.20120—
+8K120571Synthes Uss ConnectorSynthes Spine201274—
+8K113058Tiger Spine SystemCorelink, LLC201281—
+9K252139Kentrospine Viktr-MIS® Pedicle screw systemRivarp Medical Pvt., Ltd.20260—
+9K261020Symmetrix™ L Spinal SystemMedtronic Sofamor Danek USA, Inc.20260—
+9K260385aprevo® anterior and lateral lumbar interbody system; aprevo® posterior and…Carlsmed, Inc.20260—
+9K252834Sacroiliac Joint Truss System (SJTS)4Web Medical20260—
+9K250827aprevo® anterior lumbar interbody fusion device; aprevo® lateral lumbar interbody fusion…Carlsmed, Inc.20252—
+9K251080IdentiTi II Cervical Interbody SystemAlphatec Spine, Inc.20250—
+9K251617X-PAC® TLIF Expandable Posterior Cage System; X-PAC® LLIF Expandable Lateral Cage SystemExpanding Innovations, Inc.20250—
+9K241783FortiVy™ OsteoVy™ Lumbar IBFVy Spine, LLC20250—
+9K241375IdentiTi Porous Ti Interbody System; IdentiTi NanoTec Interbody System; IdentiTi…Alphatec Spine20253—
+9K242147Calibrate LTX Interbody System; Calibrate NanoTec LTX Interbody SystemAlphatec Spine, Inc.20241—
+9K241574iFuse TORQ® Implant SystemSI-BONE, Inc.20244—
+9K240368E3D™-A Interbody SystemEvolution Spine20247—
+9K240685Salvo® Spine SystemSpine Wave, Inc.20242—
+9K233951CD Horizon ModuLeX Spinal System (Shanks, Head Assemblies, and Set Screw)Medtronic Sofamor Danek USA, Inc.20245—
+9K233640Segmental Plating System (SPS);IdentiTi SPS Interbody System;IdentiTi NanoTec SPS…Alphatec Spine, Inc.20245—
+9K233366SYMPHONY OCT SystemMedos International SARL20230—
+9K232504Calibrate CCX Interbody SystemAlphatec Spine, Inc.202311
+9K230961Zeus Spinal SystemShanghai Sanyou Medical Co, Ltd.20232—
+9K232097IdentiTi ALIF Interbody SystemsAlphatec Spine, Inc.202371
+9K231931Adena-Zina Spinal SystemShanghai Sanyou Medical Co, Ltd.20230—
+9K223301ASTRA & AVANT Navigation Instruments System and ASTRA-OCT Navigation Instruments SystemSpinecraft, LLC20230—
+9K231438Calibrate PSX Interbody System, Calibrate NanoTec PSX Interbody SystemAlphatec Spine, Inc.20237—
+9K223611Calibrate LTX Interbody SystemAlphatec Spine, Inc.20237—
+9K223708Entasis 3D Dual-Lead Sacroiliac Implant SystemCorelink, LLC20233—
+9K222774iFuse Bedrock Granite® Implant SystemSI-BONE, Inc.202220—
+9K223294SpineJack® Expansion KitStryker Instruments20221—
+9K221821ATEC IOM Accessory InstrumentsAlphatec Spine, Inc.20221—
+9K221244CD Horizon™ Spinal SystemMedtronic202220—
+9K212489BonOs Inject Bone Cement; NEO Pedicle Screw SystemNeo Medical SA20215—
+9K212066Adena-Zina SystemShanghai Sanyou Medical Co, Ltd.20213—
+9K201427Trivergent Spinal Fixation SystemBenvenue Medical, Inc.20202—
+9K193270CapLOX II®/TowerLOX® MIS Pedicle Screw SystemCaptiva Spine, Inc.20200—
+9K192281AEGIS Anterior Lumbar Plate System, ALC Dynamized Fixation System, Anterior ISOLA Spine…Medos International SARL20190—
+9K191854Premia Spine XL InstrumentsPremia Spine, Ltd.20190—
+9K191835CREO Stabilization System, Navigation Instruments, ExcelsiusGPS InstrumentsGlobus Medical, Inc.20192—
+9K190163ALARA Neuro Access KitSurGenTec, LLC20192—
+9K182617ATEC IOM Accessory InstrumentsAlphatec Spine, Inc.20193—
+9K182478Whistler Modular Pedicle Screw SystemEvolution Spine, LLC20196—
+9K182954Salvo™ Spine SystemSpine Wave, Inc.20186—
+9K180475CapLOX II® / TowerLOX® MIS Pedicle Screw SystemCaptiva Spine, Inc.20180—
+9K171421VERTICALE® Posterior Spinal Fixation System/VERTICALE® SystemSilony Medical GmbH20186—
+9K172417SILC® Fixation SystemGlobus Medical, Inc.20171—
+9K162921Navigated Instrument SystemOrthofix, Inc.20175—
+9K161387Mont Blanc and Mont Blanc MIS Spinal SystemsSpineway SA20163—
+9K151977icotec Pedicle SystemIcotec AG201630—
+9K151116CapLOX II/TowerLOX Pedicle Screw SystemCaptiva Spine20153—
+9K150552ELLIPSE and PROTEX CT OCCIPITO-CERVICO-THORACIC SPINAL SYSTEMSGlobus Medical, Inc.2015961
+9K143633CREO Stabilization SystemGlobus Medical, Inc.2015158—
+9K142146Ibis Pedicle Screw SystemOrtho Development Corp.20145—
+9K133366Orthros Posterior Stabilization SystemCamber Spine20142—
+9K133564Modification to Nautilus Spinal SystemLife Spine, LLC201413—
+9K131785Pagoda Pedicle Screw SystemOrtho Development Corp.20136—
+9K121786Dymaxeon Spine SystemB2b Spine Pty, Ltd.20125—
+10K253045“Socko” Vimax Spinal Fixation SystemSocko Medical Co., Ltd.20260—
+10K260216CD Horizon™ ModuLeX™ Fenestrated Screw Set; CD Horizon™ ModuLeX™ Spinal SystemMedtronic Sofamor Danek USA, Inc.20260—
+10K253169Duet™ Spinal Fixation SystemBox Spine, LLC20261—
+10K253488iFuse INTRA Ti™ Implant SystemSI-BONE, Inc.20260—
+10K253941CD Horizon™ ModuLeX™ Spinal System (LigaMAS Head Assembly)Medtronic Sofamor Danek USA, Inc.20260—