510(k) Report

Devices descending from K020400

468 later devices reach Digitimer D185 Multipulse Cortical Stimulator through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+5K212028Dark Star Navigation Instrument SystemRepublic Spine, LLC20210—
+5K202836GX Navigation Instrument SystemLife Spine, Inc.20211—
+5K212007VERTICALE Navigation InstrumentsSilony Medical GmbH20214—
+5K211958CD Horizon Spinal SystemMedtronic Sofamor Danek USA, Inc.202115—
+5K210716CarboClear X Pedicle Screw System, CarboClear X Navigated InstrumentsCarboFix Orthopedics, Ltd.20218—
+5K203816DeGen Navigated InstrumentationDegen Medical20211—
+5K203780Harvester SI: Sacroiliac Fixation SystemSpinus International, Inc.20210—
+5K202956Erisma LP Navigated InstrumentsClariance, Sas20210—
+5K203573RESPONSE Navigation InstrumentsOrthoPediatrics Corp.20210—
+5K203291CD Horizon Spinal System InstrumentsMedtronic Sofamor Danek USA, Inc.202035—
+5K202771CD Horizon Spinal SystemMedtronic202021—
+5K200845Navigation Module of the Momentum SystemUlrich Medical USA20200—
+5K201362CD Horizon™ Fenestrated Screw Set, CD Horizon™ Spinal System, Kyphon™ HV-R™ Bone CementMedtronic202038—
+5K201251CarboClear Navigated InstrumentsCarboFix Orthopedics, Ltd.20209—
+5K190580NADIA SI Fusion SystemIlion Medical, Inc.20203—
+5K200791Navigation Enabled IntrumentsMedos International SARL20205—
+5K200095Streamline Navigated InstrumentsPioneer Surgical Technology, Inc., Dba Rti Surgical, Inc.202004
+5K192495Black Diamond Navigation InstrumentsOsseus Fusion Systems20200—
+5K190881Spinal Elements Navigated InstrumentsSpinal Elements, Inc.20194—
+5K182731Corelink Navigation InstrumentsCorelink, LLC20195—
+5K191722Vital Navigation SystemZimmer Biomet Spine, Inc.20192—
+5K191854Premia Spine XL InstrumentsPremia Spine, Ltd.20190—
+5K181606Precision Spine Navigation InstrumentationPrecision Spine, Inc.20193—
+5K191748Genesys Spine Sacroiliac Joint Fusion SystemGenesys Spine201922—
+5K191148Medtronic HV-R™ Bone Cement, Kyphon™ Xpede™ Bone Cement, CD Horizon™ Fenestrated Screw SetMedtronic Sofamor Danek USA, Inc.201950—
+5K190163ALARA Neuro Access KitSurGenTec, LLC20192—
+5K183630SPINEART Navigation Instrument SystemSpineart SA20196—
+5K183381Navigation Enabled InstrumentsStryker20191—
+5K183119SI-LOK® Sacroiliac Joint Fixation System, Navigation Instruments, ExcelsiusGPS®…Globus Medical, Inc.20192—
+5K182982BridalVeil Navigated InstrumentsAstura Medical20190—
+5K182121CD HORIZON Spinal System Instruments for use with MAZOR X Stealth EditionMedtronic Sofamor Danek USA, Inc.201841—
+5K181596Spine Wave Navigated InstrumentsSpine Wave, Inc.20181—
+5K180818Catamaran Sacroiliac Joint Fixation System (CAT SIJ Fixation System)Tenon Medical, Inc.201830—
+5K172517SeaSpine Navigation SystemSeaSpine Orthopedics Corporation2018601
+5K172166OLYMPIC Navigated InstrumentsAstura Medical20185—
+5K172115Navigated Instrument SystemOrthofix, Inc.20184—
+5K172518Spineology Navigation InstrumentsSpineology, Inc.20184—
+5K172623NuVasive Navigation InstrumentsNu Vasive, Incorporated20176—
+5K172275Vitality® Spinal Fixation System, Vitality®+ Power Instrument SystemZimmer Biomet Spine, Inc.20170—
+5K171267NavLock TrackersMedtronic Navigation201741
+5K170312IPC systems, Legend EHS handpieces and Legend Stylus Touch handpiece, Microsaw…Medtronic Powered Surgical Solutions201711—
+5K162921Navigated Instrument SystemOrthofix, Inc.20175—
+5K153587Taps for Resorbable ScrewsSynthes (USA) Products, LLC20170—
+5K161014NuVasive® Reline® SystemNu Vasive, Incorporated201648—
+5K153603Alphatec Navigation InstrumentsAlphatec Spine, Inc.201679—
+5K153203Navigation InstrumentsGlobus Medical, Inc.2016112—
+5K150231Navigated Disc Prep Instruments and CAPSTONE TrialsMedtronic Sofamor Danek USA, Inc.2015242—
+5K143375CD HORIZON Spinal System, Medtronic Navigated Reusable InstrumentsMedtronic Sofamor Danek USA, Inc.2015207—
+5K143628Navigated Vertex Select InstrumentsMedtronic Sofamor Danek USA, Inc.2015206—
+5K141968Nuvasive NVM5 SystemNuvasive, Inc.201423—
+5K131425Navigated Capstone Trials, Clydesdale Trials, Capstone & Clydesdale InserterMedtronic Navigation, Inc.201324610
+6K262193RIVA® Posterior Fixation System with NanoACTIV Surface Technology; RIVA® Anchor…Xenix Medical20260—
+6K254174Surgical Power SystemGuizhou Zirui Technology Co., Ltd.20260—
+6K262121Ion-L Navigated InstrumentsSurGenTec, LLC20260—
+6K253802KHEIRON® Spinal Fixation System, including patient specific K-RODS.M.A.I.O20261—
+6K260989Varion Thoracolumbar Fixation SystemKyocera Medical Technologies Inc. (KMTI)20260—
+6K252542LEO Spinal SystemZheJiang Decans Medical Devices Co., Ltd.20260—
+6K260216CD Horizon™ ModuLeX™ Fenestrated Screw Set; CD Horizon™ ModuLeX™ Spinal SystemMedtronic Sofamor Danek USA, Inc.20260—
+6K260011Foundation Surgical Navigated Lateral Disc Prep InstrumentsFoundation Surgical Group, Inc.20260—
+6K254158SPINEART Navigation Instrument SystemSpineart SA20261—
+6K260477CATAMARAN™ SI Joint Fusion SystemTenon Medical20260—
+6K253488iFuse INTRA Ti™ Implant SystemSI-BONE, Inc.20260—
+6K253941CD Horizon™ ModuLeX™ Spinal System (LigaMAS Head Assembly)Medtronic Sofamor Danek USA, Inc.20260—
+6K252088Firebird SI Navigation SystemOrthofix US, LLC20251—
+6K252346OLYMPIC Posterior Spinal Fixation System; MASADA Modular Spinal Fixation SystemAstura Medical20250—
+6K253331PressON Spinal Fixation SystemNexus Spine20250—
+6K250894Eminent Spine Posterior SI SystemEminent Spine20250—
+6K252437JAZZ Spinal SystemImplanet20250—
+6K251073Innovasis Navigation Instruments (Vector G-E Navigation Instruments and the Excella G-E…Innovasis, Inc.202501
+6K250908Virata Spinal Fixation SystemSeaSpine Orthopedics Corporation202521
+6K242933SPINEART Navigation Instrument SystemSpineart SA20252—
+6K242464Stealth™ Spine Clamps; ModuLeX™ Shank MountsMedtronic Navigation, Inc.20251—
+6K243945ALARA BMA Neuro Access Kit (ALARA BMAN and ALARA BMAC Kit)SurGenTec, LLC20250—
+6K250403Catamaran SI Joint Fusion SystemTenon Medical20251—
+6K243565DYNAMIS™ SI Screw SystemPromethean Restorative, LLC20251—
+6K243259MASADA Modular Spinal Fixation SystemAstura Medical20250—
+6K243106CarboClear® Hybrid Pedicle Screw SystemCarboFix Orthopedics, Ltd.20240—
+6K242350Spinal Alignment Solutions Pelvic Incidence (PI) Rod SystemSpinal Alignment Solutions, Inc.20241—
+6K241895Cannulated PsiFGuardSpineguard20240—
+6K241813SI-TECHNOLOGY® SI-DESIS® X™ Sacroiliac Joint Fusion SystemSi-Technology, LLC20241—
+6K240664ALARA BMA Neuro Access Kit (ALARA BMAN and ALARA BMAC Kit)SurGenTec, LLC20241—
+6K241644SPINEART Navigation Instrument SystemSpineart SA20243—
+6K233793CarboClear® X Pedicle Screw SystemCarboFix Orthopedics, Ltd.20241—
+6K233256Robotic Integration InstrumentsDePuy Synthes20240—
+6K233255CROSSNAV Navigation Enabled InstrumentsDePuy Synthes20242—
+6K241082INNOVERSE Navigation InstrumentsInnosys Co., Ltd.20240—
+6K240963Spinal SystemTeslake, Inc.20240—
+6K241276Vector™ Pedicle Screw SystemInnovasis, Inc.202411
+6K240392JAZZ Spinal SystemImplanet20241—
+6K240625CORUS Navigation Access SystemProvidence Medical Technology, Inc.20244—
+6K232149BowTie™ SI Joint Fusion SystemSail Fusion, LLC20242—
+6K232259Patriot-SI Posterior Implant SystemSpinal Simplicity, LLC20241—
+6K233989CarboClear® Posterior Cervical Screw SystemCarboFix Orthopedics, Ltd.20242—
+6K233508iFuse Bedrock Granite® Implant SystemSI-BONE, Inc.20245—
+6K233944CarboClear® X Pedicle Screw System; CarboClear® X Navigated InstrumentsCarboFix Orthopedics, Ltd.20243—
+6K231923Liberty SI Lateral Implant SystemSpinal Simplicity, LLC20230—
+6K231694MASADA Modular Spinal Fixation SystemAstura Medical20232—
+6K233443Vital™ Navigation SystemZimvie Spine (Zimmer Biomet Spine, Inc.)20230—
+6K233241SOLACE Sacroiliac Fixation SystemHt Medical, LLC Dba Xenix Medical20231—
+6K231527TriALTIS Navigation Enabled InstrumentsMedos International Sàrl20233—