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
+10K253335CD Horizon™ Spinal SystemMedtronic Sofamor Danek USA, Inc.20250—
+10K251965Proximity Anterior Cervical Plate System; Segmental Plating System (SPS)Alphatec Spine, Inc.20250—
+10K252113PRADO™ Lumbar Interbody Fusion SystemBethesda Medical Devices20250—
+10K250637VCFix Spinal SystemAmber Implants20250—
+10K243945ALARA BMA Neuro Access Kit (ALARA BMAN and ALARA BMAC Kit)SurGenTec, LLC20250—
+10K243838NEXXT MATRIXX® SI SystemNexxt Spine20250—
+10K243461Calibrate Interbody SystemsAlphatec Spine, Inc.20250—
+10K243565DYNAMIS™ SI Screw SystemPromethean Restorative, LLC20251—
+10K243007CD Horizon™ Spinal SystemMedtronic Sofamor Danek USA, Inc.20243—
+10K240664ALARA BMA Neuro Access Kit (ALARA BMAN and ALARA BMAC Kit)SurGenTec, LLC20241—
+10K240505Eminent Spine SI Screw SystemEminent Spine, LLC20241—
+10K233332Statera-C™ Spinal SystemK&J Consulting Corp.20230—
+10K232605Sacrix® Sacroiliac Joint Fusion Device System, Inspan® ScrewLES Fusion System, Invue®…Lesspine Innovations20230—
+10K232141CD Horizon ModuLeX FNS Screw Set (Fenestrated Screw); CD Horizon ModuLeX Spinal System…Medtronic Sofamor Danek USA, Inc.20231—
+10K223806VERTICALE® Triangular Fixation SystemSilony Medical GmbH20230—
+10K223765ATEC Lateral Navigation InstrumentsAlphatec Spine, Inc.202302
+10K223494CD Horizon Spinal SystemMedtronic202317—
+10K222256BonOs® Inject Bone Cement; NEO Pedicle Screw System™Neo Medical SA20223—
+10K203023Pisces Spinal SystemOrtho Development Corporation20210—
+10K191723ATEC IOM Accessory InstrumentsAlphatec Spine, Inc.20192—
+10K191045Salvo™ Spine SystemSpine Wave, Inc.20195—
+10K182508Saxxony™ Posterior Cervical Thoracic SystemNexxt Spine, LLC20184—
+10K181350ASTRA-OCT Spine SystemSpinecraft, LLC20180—
+10K172105The Plateau-LO Spacer SystemLife Spine, Inc.20181—
+10K161591QUARTEX™ Occipito-Cervico-Thoracic Spinal System, Globus Navigation InstrumentsGlobus Medical, Inc.201678—
+10K160020Captiva Spine and CapLOX II/TowerLOX Pedicle Screw SystemCaptiva Spine20160—
+10K153370Caspian OCT/MESA Mini/DENALI Mini Spinal SystemK2m, Incorporated201617—
+10K140457Nautilus Spinal SystemLife Spine, Inc.20143—
+11K262712Duet™ Spinal Fixation SystemDuet Spine Holdings, LLC20260—
+11K253802KHEIRON® Spinal Fixation System, including patient specific K-RODS.M.A.I.O20261—
+11K260011Foundation Surgical Navigated Lateral Disc Prep InstrumentsFoundation Surgical Group, Inc.20260—
+11K253331PressON Spinal Fixation SystemNexus Spine20250—
+11K250894Eminent Spine Posterior SI SystemEminent Spine20250—
+11K242674Freedom Posterior Cervical ScrewsSignature Orthopaedics Pty, Ltd.20250—
+11K251075DYNAMIS™ Implant SystemPromethean Restorative, LLC20250—
+11K243693NEO Pedicle Screw System™Neo Medical SA20240—
+11K241082INNOVERSE Navigation InstrumentsInnosys Co., Ltd.20240—
+11K211957QUARTEX Occipito-Cervico-Thoracic Spinal System, Globus Navigation InstrumentsGlobus Medical, Inc.20213—
+11K202476Salvo® Spine SystemSpine Wave, Inc.20204—
+11K182470Plateau Spacer SystemLife Spine20180—
+11K182182YUKON OCT Spinal SystemK2m20185—
+11K180690Navigation InstrumentsGlobus Medical, Inc.20189—
+11K171444YUKON OCT Spinal SystemK2m, Inc.2017133
+11K162266The Cranial Fusion SystemLife Spine, Inc.20171—
+12K222107Black Diamond™ POCT Spinal SystemOsseus Fusion Systems20220—
+12K222362Salvo® Spine SystemSpine Wave, Inc.20223—
+12K200896Solstice CCILife Spine, Inc.20200—
+12K193129Yukon OCT Spinal SystemK2m, Inc.202001
+12K183381Navigation Enabled InstrumentsStryker20191—