510(k) Report

Devices descending from K982990

776 later devices reach TSRH Spinal System through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+7K212825CoreLink Navigation InstrumentsCorelink, LLC20214—
+7K211958CD Horizon Spinal SystemMedtronic Sofamor Danek USA, Inc.202115—
+7K203023Pisces Spinal SystemOrtho Development Corporation20210—
+7K201737Posterior Spinal Fixation SystemShanghai Reach Medical Instrument Co, Ltd.20211—
+7K202458BonOs Inject, Pedicle screw kits, Cement pusherOsartis GmbH20216—
+7K210427M.U.S.T. Midline Cortical (MC) Screw SystemMedacta International S.A.20210—
+7K210539CoreLink Midline Fixation SystemCorelink, LLC20214—
+7K203482M.U.S.T. Pedicle Screw Extension and Long Tab ImplantsMedacta International S.A.20215—
+7K203506PERLA® TL posterior osteosynthesis systemSpineart202132
+7K203678CD HORIZON™ Spinal SystemMedtronic Sofamor Danek USA, Inc.202135—
+7K203222PERLA TL Posterior Osteosynthesis SystemSpineart20204—
+7K203163ARx Illiac Spinal Screw SystemLife Spine, Inc.20205—
+7K202476Salvo® Spine SystemSpine Wave, Inc.20204—
+7K201362CD Horizon™ Fenestrated Screw Set, CD Horizon™ Spinal System, Kyphon™ HV-R™ Bone CementMedtronic202038—
+7K201648Sterispine™ PSSafe Orthopaedics202011
+7K192930Dymaxeon Spine SystemBack 2 Basics Direct, LLC20201—
+7K200896Solstice CCILife Spine, Inc.20200—
+7K193129Yukon OCT Spinal SystemK2m, Inc.202001
+7K193365M.U.S.T. Pedicle Screw SystemMedacta International S.A.20207—
+7K193011CD Horizon™ Fenestrated Screw SetMedtronic Sofamor Danek USA, Inc.202041—
+7K191722Vital Navigation SystemZimmer Biomet Spine, Inc.20192—
+7K191854Premia Spine XL InstrumentsPremia Spine, Ltd.20190—
+7K191576Mercury® Spinal System, Overwatch® Spinal SystemSpinal Elements, Inc.20195—
+7K191148Medtronic HV-R™ Bone Cement, Kyphon™ Xpede™ Bone Cement, CD Horizon™ Fenestrated Screw SetMedtronic Sofamor Danek USA, Inc.201950—
+7K183091Elaris Pedicle Screw SystemSpinewelding AG20190—
+7K182416NOVA Minimally Invasive SystemBaui Biotech Co., Ltd.20192—
+7K182544AccelFix Spinal Fixation SystemL&K BIOMED Co., Ltd.201910—
+7K183639Mariner Outrigger Revision SystemSeaSpine Orthopedics Corporation20198—
+7K183381Navigation Enabled InstrumentsStryker20191—
+7K182974NuVasive Reline SystemNu Vasive, Incorporated201911—
+7K182928CD Horizon™ Spinal SystemMedtronic Sofamor Danek USA, Inc.201953—
+7K183168OpenLoc-L Spinal Fixation SystemL&K BIOMED Co., Ltd.201823—
+7K183080Mega Plus Spine SystemBk Meditech, Co., Ltd.20182—
+7K180754C-Zero Pedicle Screw System, Freedom Pedicle Screw SystemSignature Orthopaedics Pty, Ltd.20180—
+7K180498NuVasive Reline Fenestrated Screws, High V+ Bone CementNu Vasive, Incorporated201841—
+7K180179Firebird® Spinal Fixation Systems: Firebird System; Firebird Deformity System; Firebird®…Orthofix, Inc.201837—
+7K173487CarboClear® Pedicle Screw SystemCarboFix Orthopedics, Ltd.201841—
+7K172269FORTRESS™ Radiopaque Bone Cement (FORTRESS™ and FORTRESS-Plus™), CREO® Fenestrated Screw…Globus Medical, Inc.20184—
+7K173249CD HORIZON™ Spinal SystemMedtronic Sofamor Danek USA, Inc.20181—
+7K172518Spineology Navigation InstrumentsSpineology, Inc.20184—
+7K173130Reform® Midline Cortical Screw SystemPrecision Spine, Inc.201721—
+7K171938KYPHON Xpede Bone Cement, CD HORIZON Fenestrated Screw SetMedtronic201764—
+7K172275Vitality® Spinal Fixation System, Vitality®+ Power Instrument SystemZimmer Biomet Spine, Inc.20170—
+7K163375INFINITY™ OCT SystemMedtronic Sofamor Danek USA, Inc.2017165
+7K172194Connector SystemOrthofix, Inc.2017162
+7K161225Paonan Armstrong Posterior Spinal Fixation SystemPaonan Biotech Co., Ltd.20172—
+7K170861PremierShandong Weigao Orthopaedic Device Co., Ltd.20170—
+7K171758M.U.S.T. Combined Set ScrewsMedacta International S.A.20177—
+7K171907Vitality® Spinal Fixation SystemZimmer Biomet Spine, Inc.2017162
+7K171170M.U.S.T. Pedicle Screw System Extension - Straight Connectors and Additional ScrewsMedacta International S.A.201723—
+7K170989Dymaxeon Spine SystemBack 2 Basics Direct, LLC20172—
+7K163363SurgTech Thoracolumbosacral (TLS) Posterior Fixation SystemSurgtech, Inc.20170—
+7K162995Ibis® Pedicle Screw SystemOrtho Development Corporation20173—
+7K162921Navigated Instrument SystemOrthofix, Inc.20175—
+7K163301CD HORIZON® Spinal SystemMedtronic Sofamor Danek USA, Inc.20162—
+7K160879CONFIDENCE™ High Viscosity Spinal Cement, VIPER® and EXPEDIUM® Fenestrated Screw SystemsMedos International Sàrl2016106—
+7K162061M.U.S.T. Pedicle Screw SystemMedacta International S.A.201615—
+7K162494CD HORIZON® Spinal SystemMedtronic Sofamor Danek USA, Inc.201627—
+7K161014NuVasive® Reline® SystemNu Vasive, Incorporated201648—
+7K153589CD HORIZON Spinal SystemMedtronic Sofamor Danek USA, Inc.201610—
+7K153664M.U.S.T. Pedicle Screw SystemMedacta International201624—
+7K151648Altus Spine Pedicle Screw System, Altus Spine MIS Pedicle Screw System, Valencia Pedicle…Altus Partners, LLC20155—
+7K151216Everest Spinal SystemK2m, Inc.201511—
+7K143684NuVasive Reline SystemNu Vasive, Incorporated201577—
+7K143731IMPLANET Spine System (ISS)Implanet, S.A.20158—
+7K142531F1-Modular Pedicle Screw SystemDegen Medical20152—
+7K143375CD HORIZON Spinal System, Medtronic Navigated Reusable InstrumentsMedtronic Sofamor Danek USA, Inc.2015207—
+7K150178CD Horizon Spinal SystemMedtronic Sofamor Danek USA, Inc.201525—
+7K141988M.U.S.T Pedicle Screw SystemMedacta International201426—
+7K141044M.U.S.T. ExtensionMedacta International201416—
+7K141605CD Horizon Spinal SystemMedtronic Sofamor Danek USA, Inc.2014210—
+7K132788Myspine Pedicle Screw Placement GuidesMedacta International201412—
+7K140010Fortress Pedicle Screw SystemSpineology, Inc.201411—
+7K140696Streamline TL Spinal Fixation SystemPioneer Surgical Technology, Inc.20145—
+7K140457Nautilus Spinal SystemLife Spine, Inc.20143—
+7K133221Arsenal Spinal Fixation SystemAlphatec Spine, Inc.20141502
+7K140276CD Horizon Spinal SystemMedtronic Sofamor Danek201485—
+7K132878M.U.S.T. ExtensionMedacta International201328—
+7K132303Implanet Spine SystemImplanet, S.A.201315—
+7K132111CD Horizon Spinal SystemMedtronic Sofamor Danek USA2013100—
+7K122332Towerlox Pedicle Screw SystemCaptiva Spine201214—
+8K261882Pisces-SC Standalone Cervical Interbody SystemOsseus Fusions Systems, LLC20260—
+8K261205SPINEART Navigation Instrument SystemSpineart SA20260—
+8K253943Tiger 2 SystemZavation Medical Products, LLC20260—
+8K262094E3D™-C Interbody SystemEvolution Spine20260—
+8K260286Dynamo™ Spinal Cement; Salvo® Spine SystemSpine Wave, Inc.20260—
+8K260036NeckTune™ 3D SA Cervical CageMedyssey Co, Ltd.20260—
+8K251251ChanPin Pedicle Screw Spinal SystemChanpin Medtak Co., Ltd.20260—
+8K260385aprevo® anterior and lateral lumbar interbody system; aprevo® posterior and…Carlsmed, Inc.20260—
+8K254105Hive™ Standalone Cervical System and Hive™ C Interbody SystemNanoHive Medical, LLC20260—
+8K260038E3D™-C Interbody SystemEvolution Spine20261—
+8K252885OLYMPIC Posterior Spinal Fixation System; MASADA Modular Spinal Fixation SystemAstura Medical20260—
+8K252894aprevo® cervical interbody systemCarlsmed, Inc.20261—
+8K253129Infinity™ OCT SystemMedtronic Sofamor Danek USA, Inc.20250—
+8K251965Proximity Anterior Cervical Plate System; Segmental Plating System (SPS)Alphatec Spine, Inc.20250—
+8K252113PRADO™ Lumbar Interbody Fusion SystemBethesda Medical Devices20250—
+8K251644ProAM ALIF SystemPro Surgical, Inc.20250—
+8K250667DeGen Medical Patient Specific Implant (PSI) SystemDegen Medical20251—
+8K243802aprevo® anterior and lateral lumbar interbody fusion device, aprevo® anterior lumbar…Carlsmed, Inc.20253—
+8K243461Calibrate Interbody SystemsAlphatec Spine, Inc.20250—