510(k) Report

Devices descending from K072317

625 later devices reach Modification to:TSRH Spinal System through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+6K243007CD Horizon™ Spinal SystemMedtronic Sofamor Danek USA, Inc.20243—
+6K230325GREENS BRAND Posterior, Non-cervical Pedicle Screw Spinal SystemGreens Surgicals Pvt., Ltd.20240—
+6K241082INNOVERSE Navigation InstrumentsInnosys Co., Ltd.20240—
+6K241034Meta+ Bone Cement & M.U.S.T. Fenestrated Pedicle Screw SystemMedacta International S.A.20242—
+6K240846CarboClear® Hybrid Pedicle Screw System; CarboClear® Hybrid Navigated Instruments…CarboFix Orthopedics, Ltd.20242—
+6K233951CD Horizon ModuLeX Spinal System (Shanks, Head Assemblies, and Set Screw)Medtronic Sofamor Danek USA, Inc.20245—
+6K234048M.U.S.T. Pedicle Screw System - ExtensionMedacta International S.A.20241—
+6K233508iFuse Bedrock Granite® Implant SystemSI-BONE, Inc.20245—
+6K230961Zeus Spinal SystemShanghai Sanyou Medical Co, Ltd.20232—
+6K232141CD Horizon ModuLeX FNS Screw Set (Fenestrated Screw); CD Horizon ModuLeX Spinal System…Medtronic Sofamor Danek USA, Inc.20231—
+6K231931Adena-Zina Spinal SystemShanghai Sanyou Medical Co, Ltd.20230—
+6K223301ASTRA & AVANT Navigation Instruments System and ASTRA-OCT Navigation Instruments SystemSpinecraft, LLC20230—
+6K223808Zavation Navigation Instrument SystemZavation Medical Products, LLC20230—
+6K230774PERLA® TL System; TEKTONA® HV US Bone CementSpineart20230—
+6K230880CoreLink Navigation InstrumentsCorelink, LLC20230—
+6K221646CD HORIZON™ ASTUTE™ SPINAL SYSTEM; CD HORIZON™ Growth Rod Conversion Set; CD HORIZON™…Medtronic Sofamor Danek USA, Inc.202220—
+6K221905INERTIA CONNEXX Modular Pedicle Screw SystemNexxt Spine, LLC20221—
+6K220973CoreLink Navigation InstrumentsCorelink, LLC20221—
+6K213491Universal Pilot Guidance Instrument SystemCtl Medical Corporation20220—
+6K220038Camber Spine Navigation SystemCamber Spine Technologies20220—
+6K213470PERLA® TL Posterior Osteosynthesis SystemSpineart20222—
+6K213281PASS LP™ Spinal System, CD Horizon™ Spinal SystemMedicrea International SA20220—
+6K212489BonOs Inject Bone Cement; NEO Pedicle Screw SystemNeo Medical SA20215—
+6K212825CoreLink Navigation InstrumentsCorelink, LLC20214—
+6K211958CD Horizon Spinal SystemMedtronic Sofamor Danek USA, Inc.202115—
+6K201737Posterior Spinal Fixation SystemShanghai Reach Medical Instrument Co, Ltd.20211—
+6K211323ASTRA Spine SystemSpinecraft, LLC202112—
+6K211057LigaPASS® Spinal System, CD Horizon™ Spinal SystemMedtronic, Inc.20211—
+6K210306GII Spinal Fixation SystemColigne AG20210—
+6K202458BonOs Inject, Pedicle screw kits, Cement pusherOsartis GmbH20216—
+6K210427M.U.S.T. Midline Cortical (MC) Screw SystemMedacta International S.A.20210—
+6K210716CarboClear X Pedicle Screw System, CarboClear X Navigated InstrumentsCarboFix Orthopedics, Ltd.20218—
+6K203482M.U.S.T. Pedicle Screw Extension and Long Tab ImplantsMedacta International S.A.20215—
+6K203506PERLA® TL posterior osteosynthesis systemSpineart202132
+6K203678CD HORIZON™ Spinal SystemMedtronic Sofamor Danek USA, Inc.202135—
+6K203163ARx Illiac Spinal Screw SystemLife Spine, Inc.20205—
+6K201362CD Horizon™ Fenestrated Screw Set, CD Horizon™ Spinal System, Kyphon™ HV-R™ Bone CementMedtronic202038—
+6K201251CarboClear Navigated InstrumentsCarboFix Orthopedics, Ltd.20209—
+6K201648Sterispine™ PSSafe Orthopaedics202011
+6K193365M.U.S.T. Pedicle Screw SystemMedacta International S.A.20207—
+6K193011CD Horizon™ Fenestrated Screw SetMedtronic Sofamor Danek USA, Inc.202041—
+6K191854Premia Spine XL InstrumentsPremia Spine, Ltd.20190—
+6K191148Medtronic HV-R™ Bone Cement, Kyphon™ Xpede™ Bone Cement, CD Horizon™ Fenestrated Screw SetMedtronic Sofamor Danek USA, Inc.201950—
+6K183091Elaris Pedicle Screw SystemSpinewelding AG20190—
+6K182928CD Horizon™ Spinal SystemMedtronic Sofamor Danek USA, Inc.201953—
+6K180498NuVasive Reline Fenestrated Screws, High V+ Bone CementNu Vasive, Incorporated201841—
+6K173487CarboClear® Pedicle Screw SystemCarboFix Orthopedics, Ltd.201841—
+6K181139OLYMPIC Posterior Spinal Fixation SystemAstura Medical, LLC20188—
+6K172269FORTRESS™ Radiopaque Bone Cement (FORTRESS™ and FORTRESS-Plus™), CREO® Fenestrated Screw…Globus Medical, Inc.20184—
+6K173180Mega Plus Spine SystemBk Meditech, Co., Ltd.20183—
+6K173249CD HORIZON™ Spinal SystemMedtronic Sofamor Danek USA, Inc.20181—
+6K172115Navigated Instrument SystemOrthofix, Inc.20184—
+6K172518Spineology Navigation InstrumentsSpineology, Inc.20184—
+6K171938KYPHON Xpede Bone Cement, CD HORIZON Fenestrated Screw SetMedtronic201764—
+6K172275Vitality® Spinal Fixation System, Vitality®+ Power Instrument SystemZimmer Biomet Spine, Inc.20170—
+6K171832Range/Denali/Mesa Spinal SystemK2m, Inc.201713—
+6K163375INFINITY™ OCT SystemMedtronic Sofamor Danek USA, Inc.2017165
+6K171758M.U.S.T. Combined Set ScrewsMedacta International S.A.20177—
+6K171170M.U.S.T. Pedicle Screw System Extension - Straight Connectors and Additional ScrewsMedacta International S.A.201723—
+6K163363SurgTech Thoracolumbosacral (TLS) Posterior Fixation SystemSurgtech, Inc.20170—
+6K162921Navigated Instrument SystemOrthofix, Inc.20175—
+6K163301CD HORIZON® Spinal SystemMedtronic Sofamor Danek USA, Inc.20162—
+6K160879CONFIDENCE™ High Viscosity Spinal Cement, VIPER® and EXPEDIUM® Fenestrated Screw SystemsMedos International Sàrl2016106—
+6K162134ENNOVATE Spinal SystemAesculap Implant Systems, LLC20162—
+6K162061M.U.S.T. Pedicle Screw SystemMedacta International S.A.201615—
+6K162494CD HORIZON® Spinal SystemMedtronic Sofamor Danek USA, Inc.201627—
+6K161014NuVasive® Reline® SystemNu Vasive, Incorporated201648—
+6K161028K2M Growing Spine SystemK2m, Inc.20163—
+6K153453Inertia Pedicle Screw and Deformity Correxxion SystemNexxt Spine, LLC201617—
+6K153589CD HORIZON Spinal SystemMedtronic Sofamor Danek USA, Inc.201610—
+6K153664M.U.S.T. Pedicle Screw SystemMedacta International201624—
+6K151770Libra Pedicle Screw SystemSpinal Balance, Inc.20151—
+6K151974Polaris Spinal SystemBiomet Spine201516—
+6K151727Everest Spinal SystemK2m, Inc.201511—
+6K150896Vitality Spinal Fixation SystemZimmer Spine, Inc.2015193
+6K151422Reform Pedicle Screw SystemPrecision Spine, Inc.201519—
+6K143684NuVasive Reline SystemNu Vasive, Incorporated201577—
+6K143731IMPLANET Spine System (ISS)Implanet, S.A.20158—
+6K142531F1-Modular Pedicle Screw SystemDegen Medical20152—
+6K143375CD HORIZON Spinal System, Medtronic Navigated Reusable InstrumentsMedtronic Sofamor Danek USA, Inc.2015207—
+6K150178CD Horizon Spinal SystemMedtronic Sofamor Danek USA, Inc.201525—
+6K142360Everest Spinal SystemK2m, Inc.201522—
+6K141253New Era Orthopaedics Polyscrew Pedicle Screw SystemNew Era Orthopaedics, LLC201511
+6K143248Reform Pedicle Screw SystemPrecision Spine, Inc.201430—
+6K141873Range/Mesa/Denali Spinal SystemK2m, Inc.201430—
+6K141988M.U.S.T Pedicle Screw SystemMedacta International201426—
+6K141044M.U.S.T. ExtensionMedacta International201416—
+6K141605CD Horizon Spinal SystemMedtronic Sofamor Danek USA, Inc.2014210—
+6K140765Range/Mesa/Denali Spinal SystemK2m, Inc.201415—
+6K141147Range Spinal SystemK2m, Inc.20141—
+6K132788Myspine Pedicle Screw Placement GuidesMedacta International201412—
+6K140529Everest Spinal SystemK2m, LLC201431—
+6K140123Polaris Spinal System -Translation ScrewEbi, LLC2014221
+6K140010Fortress Pedicle Screw SystemSpineology, Inc.201411—
+6K140696Streamline TL Spinal Fixation SystemPioneer Surgical Technology, Inc.20145—
+6K140457Nautilus Spinal SystemLife Spine, Inc.20143—
+6K133221Arsenal Spinal Fixation SystemAlphatec Spine, Inc.20141502
+6K140276CD Horizon Spinal SystemMedtronic Sofamor Danek201485—
+6K133350Revere Stabilization SystemGlobus Medical, Inc.201493—
+6K132878M.U.S.T. ExtensionMedacta International201328—