510(k) Report

Devices descending from K900482

465 later devices reach Software & Hardware Addition to Sentinel-4 Eeg through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+8K201362CD Horizon™ Fenestrated Screw Set, CD Horizon™ Spinal System, Kyphon™ HV-R™ Bone CementMedtronic202038—
+8K201251CarboClear Navigated InstrumentsCarboFix Orthopedics, Ltd.20209—
+8K190580NADIA SI Fusion SystemIlion Medical, Inc.20203—
+8K200791Navigation Enabled IntrumentsMedos International SARL20205—
+8K200095Streamline Navigated InstrumentsPioneer Surgical Technology, Inc., Dba Rti Surgical, Inc.202004
+8K192495Black Diamond Navigation InstrumentsOsseus Fusion Systems20200—
+8K190881Spinal Elements Navigated InstrumentsSpinal Elements, Inc.20194—
+8K182731Corelink Navigation InstrumentsCorelink, LLC20195—
+8K191722Vital Navigation SystemZimmer Biomet Spine, Inc.20192—
+8K191723ATEC IOM Accessory InstrumentsAlphatec Spine, Inc.20192—
+8K191854Premia Spine XL InstrumentsPremia Spine, Ltd.20190—
+8K181606Precision Spine Navigation InstrumentationPrecision Spine, Inc.20193—
+8K191748Genesys Spine Sacroiliac Joint Fusion SystemGenesys Spine201922—
+8K191148Medtronic HV-R™ Bone Cement, Kyphon™ Xpede™ Bone Cement, CD Horizon™ Fenestrated Screw SetMedtronic Sofamor Danek USA, Inc.201950—
+8K183630SPINEART Navigation Instrument SystemSpineart SA20196—
+8K183381Navigation Enabled InstrumentsStryker20191—
+8K183119SI-LOK® Sacroiliac Joint Fixation System, Navigation Instruments, ExcelsiusGPS®…Globus Medical, Inc.20192—
+8K182982BridalVeil Navigated InstrumentsAstura Medical20190—
+8K182121CD HORIZON Spinal System Instruments for use with MAZOR X Stealth EditionMedtronic Sofamor Danek USA, Inc.201841—
+8K181596Spine Wave Navigated InstrumentsSpine Wave, Inc.20181—
+8K181466Cadwell Zenith SystemCadwell Industries, Inc.20180—
+8K180818Catamaran Sacroiliac Joint Fixation System (CAT SIJ Fixation System)Tenon Medical, Inc.201830—
+8K172517SeaSpine Navigation SystemSeaSpine Orthopedics Corporation2018601
+8K172166OLYMPIC Navigated InstrumentsAstura Medical20185—
+8K172115Navigated Instrument SystemOrthofix, Inc.20184—
+8K172518Spineology Navigation InstrumentsSpineology, Inc.20184—
+8K172623NuVasive Navigation InstrumentsNu Vasive, Incorporated20176—
+8K172275Vitality® Spinal Fixation System, Vitality®+ Power Instrument SystemZimmer Biomet Spine, Inc.20170—
+8K171807ES2 Neuromonitoring Accessory InstrumentsStryker Corporation20177—
+8K171267NavLock TrackersMedtronic Navigation201741
+8K170312IPC systems, Legend EHS handpieces and Legend Stylus Touch handpiece, Microsaw…Medtronic Powered Surgical Solutions201711—
+8K162921Navigated Instrument SystemOrthofix, Inc.20175—
+8K153587Taps for Resorbable ScrewsSynthes (USA) Products, LLC20170—
+8K161014NuVasive® Reline® SystemNu Vasive, Incorporated201648—
+8K153603Alphatec Navigation InstrumentsAlphatec Spine, Inc.201679—
+8K153203Navigation InstrumentsGlobus Medical, Inc.2016112—
+8K150231Navigated Disc Prep Instruments and CAPSTONE TrialsMedtronic Sofamor Danek USA, Inc.2015242—
+8K142438Nerve Monitoring Cable SystemPioneer Surgical Technology, Inc. (Rti Surgical, Inc.)20154—
+8K143375CD HORIZON Spinal System, Medtronic Navigated Reusable InstrumentsMedtronic Sofamor Danek USA, Inc.2015207—
+8K143628Navigated Vertex Select InstrumentsMedtronic Sofamor Danek USA, Inc.2015206—
+8K132694Nuvasive NVM5 SystemNu Vasive, Incorporated201424—
+8K131425Navigated Capstone Trials, Clydesdale Trials, Capstone & Clydesdale InserterMedtronic Navigation, Inc.201324610
+9K262193RIVA® Posterior Fixation System with NanoACTIV Surface Technology; RIVA® Anchor…Xenix Medical20260—
+9K254174Surgical Power SystemGuizhou Zirui Technology Co., Ltd.20260—
+9K262121Ion-L Navigated InstrumentsSurGenTec, LLC20260—
+9K253802KHEIRON® Spinal Fixation System, including patient specific K-RODS.M.A.I.O20261—
+9K260989Varion Thoracolumbar Fixation SystemKyocera Medical Technologies Inc. (KMTI)20260—
+9K252542LEO Spinal SystemZheJiang Decans Medical Devices Co., Ltd.20260—
+9K260216CD Horizon™ ModuLeX™ Fenestrated Screw Set; CD Horizon™ ModuLeX™ Spinal SystemMedtronic Sofamor Danek USA, Inc.20260—
+9K260011Foundation Surgical Navigated Lateral Disc Prep InstrumentsFoundation Surgical Group, Inc.20260—
+9K254158SPINEART Navigation Instrument SystemSpineart SA20261—
+9K260477CATAMARAN™ SI Joint Fusion SystemTenon Medical20260—
+9K253488iFuse INTRA Ti™ Implant SystemSI-BONE, Inc.20260—
+9K252842SafeOp 3: Neural Informatix SystemAlphatec Spine, Inc.202601
+9K253941CD Horizon™ ModuLeX™ Spinal System (LigaMAS Head Assembly)Medtronic Sofamor Danek USA, Inc.20260—
+9K252088Firebird SI Navigation SystemOrthofix US, LLC20251—
+9K252346OLYMPIC Posterior Spinal Fixation System; MASADA Modular Spinal Fixation SystemAstura Medical20250—
+9K253331PressON Spinal Fixation SystemNexus Spine20250—
+9K250894Eminent Spine Posterior SI SystemEminent Spine20250—
+9K252437JAZZ Spinal SystemImplanet20250—
+9K251073Innovasis Navigation Instruments (Vector G-E Navigation Instruments and the Excella G-E…Innovasis, Inc.202501
+9K250908Virata Spinal Fixation SystemSeaSpine Orthopedics Corporation202521
+9K242933SPINEART Navigation Instrument SystemSpineart SA20252—
+9K242464Stealth™ Spine Clamps; ModuLeX™ Shank MountsMedtronic Navigation, Inc.20251—
+9K250403Catamaran SI Joint Fusion SystemTenon Medical20251—
+9K243565DYNAMIS™ SI Screw SystemPromethean Restorative, LLC20251—
+9K243259MASADA Modular Spinal Fixation SystemAstura Medical20250—
+9K243106CarboClear® Hybrid Pedicle Screw SystemCarboFix Orthopedics, Ltd.20240—
+9K242350Spinal Alignment Solutions Pelvic Incidence (PI) Rod SystemSpinal Alignment Solutions, Inc.20241—
+9K241895Cannulated PsiFGuardSpineguard20240—
+9K241813SI-TECHNOLOGY® SI-DESIS® X™ Sacroiliac Joint Fusion SystemSi-Technology, LLC20241—
+9K241644SPINEART Navigation Instrument SystemSpineart SA20243—
+9K233793CarboClear® X Pedicle Screw SystemCarboFix Orthopedics, Ltd.20241—
+9K233256Robotic Integration InstrumentsDePuy Synthes20240—
+9K233255CROSSNAV Navigation Enabled InstrumentsDePuy Synthes20242—
+9K241082INNOVERSE Navigation InstrumentsInnosys Co., Ltd.20240—
+9K240963Spinal SystemTeslake, Inc.20240—
+9K241276Vector™ Pedicle Screw SystemInnovasis, Inc.202411
+9K240392JAZZ Spinal SystemImplanet20241—
+9K240625CORUS Navigation Access SystemProvidence Medical Technology, Inc.20244—
+9K232149BowTie™ SI Joint Fusion SystemSail Fusion, LLC20242—
+9K232259Patriot-SI Posterior Implant SystemSpinal Simplicity, LLC20241—
+9K233989CarboClear® Posterior Cervical Screw SystemCarboFix Orthopedics, Ltd.20242—
+9K233508iFuse Bedrock Granite® Implant SystemSI-BONE, Inc.20245—
+9K233944CarboClear® X Pedicle Screw System; CarboClear® X Navigated InstrumentsCarboFix Orthopedics, Ltd.20243—
+9K231923Liberty SI Lateral Implant SystemSpinal Simplicity, LLC20230—
+9K231694MASADA Modular Spinal Fixation SystemAstura Medical20232—
+9K233443Vital™ Navigation SystemZimvie Spine (Zimmer Biomet Spine, Inc.)20230—
+9K233292ISIS Headboxes, ISIS Neurostimulator, ISIS Xpert Plus, ISIS Xpert, ISIS XpressInomed Medizintechnik GmbH20231—
+9K233241SOLACE Sacroiliac Fixation SystemHt Medical, LLC Dba Xenix Medical20231—
+9K231527TriALTIS Navigation Enabled InstrumentsMedos International Sàrl20233—
+9K230857TiLink-P SI Joint Fusion SystemSurGenTec, LLC20234—
+9K231944CATAMARAN SI Joint Fusion SystemTenon Medical, Inc.20234—
+9K232141CD Horizon ModuLeX FNS Screw Set (Fenestrated Screw); CD Horizon ModuLeX Spinal System…Medtronic Sofamor Danek USA, Inc.20231—
+9K230716Robotic Graft Delivery InstrumentsMedtronic Sofamor Danek, Inc.20230—
+9K231280CarboClear® X Pedicle Screw System; CarboClear® X Navigated Instruments; CarboClear® X…CarboFix Orthopedics, Ltd.20234—
+9K231184CD Horizon™ Spinal SystemMedtronic Sofamor Danek USA, Inc.20230—
+9K231229S-COMP Reform® POCT Navigation InstrumentsPrecision Spine, Inc.20230—
+9K220274Kisar Stratford SI Screw SystemAnjali Investments L.L.C20230—
+9K213815SiJoin®T3Vgi Medical, Inc.20230—