510(k) Report

Devices descending from K003681

478 later devices reach Bio-Logic Sleepscan Netlink through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+6K212825CoreLink Navigation InstrumentsCorelink, LLC20214—
+6K212028Dark Star Navigation Instrument SystemRepublic Spine, LLC20210—
+6K202836GX Navigation Instrument SystemLife Spine, Inc.20211—
+6K212007VERTICALE Navigation InstrumentsSilony Medical GmbH20214—
+6K211958CD Horizon Spinal SystemMedtronic Sofamor Danek USA, Inc.202115—
+6K210716CarboClear X Pedicle Screw System, CarboClear X Navigated InstrumentsCarboFix Orthopedics, Ltd.20218—
+6K203816DeGen Navigated InstrumentationDegen Medical20211—
+6K203780Harvester SI: Sacroiliac Fixation SystemSpinus International, Inc.20210—
+6K202956Erisma LP Navigated InstrumentsClariance, Sas20210—
+6K203573RESPONSE Navigation InstrumentsOrthoPediatrics Corp.20210—
+6K203291CD Horizon Spinal System InstrumentsMedtronic Sofamor Danek USA, Inc.202035—
+6K202771CD Horizon Spinal SystemMedtronic202021—
+6K200845Navigation Module of the Momentum SystemUlrich Medical USA20200—
+6K201362CD Horizon™ Fenestrated Screw Set, CD Horizon™ Spinal System, Kyphon™ HV-R™ Bone CementMedtronic202038—
+6K201251CarboClear Navigated InstrumentsCarboFix Orthopedics, Ltd.20209—
+6K190580NADIA SI Fusion SystemIlion Medical, Inc.20203—
+6K200791Navigation Enabled IntrumentsMedos International SARL20205—
+6K200095Streamline Navigated InstrumentsPioneer Surgical Technology, Inc., Dba Rti Surgical, Inc.202004
+6K192495Black Diamond Navigation InstrumentsOsseus Fusion Systems20200—
+6K190881Spinal Elements Navigated InstrumentsSpinal Elements, Inc.20194—
+6K182731Corelink Navigation InstrumentsCorelink, LLC20195—
+6K191722Vital Navigation SystemZimmer Biomet Spine, Inc.20192—
+6K191723ATEC IOM Accessory InstrumentsAlphatec Spine, Inc.20192—
+6K191854Premia Spine XL InstrumentsPremia Spine, Ltd.20190—
+6K181606Precision Spine Navigation InstrumentationPrecision Spine, Inc.20193—
+6K191748Genesys Spine Sacroiliac Joint Fusion SystemGenesys Spine201922—
+6K191148Medtronic HV-R™ Bone Cement, Kyphon™ Xpede™ Bone Cement, CD Horizon™ Fenestrated Screw SetMedtronic Sofamor Danek USA, Inc.201950—
+6K183630SPINEART Navigation Instrument SystemSpineart SA20196—
+6K183381Navigation Enabled InstrumentsStryker20191—
+6K183119SI-LOK® Sacroiliac Joint Fixation System, Navigation Instruments, ExcelsiusGPS®…Globus Medical, Inc.20192—
+6K182982BridalVeil Navigated InstrumentsAstura Medical20190—
+6K182121CD HORIZON Spinal System Instruments for use with MAZOR X Stealth EditionMedtronic Sofamor Danek USA, Inc.201841—
+6K181596Spine Wave Navigated InstrumentsSpine Wave, Inc.20181—
+6K181466Cadwell Zenith SystemCadwell Industries, Inc.20180—
+6K180818Catamaran Sacroiliac Joint Fixation System (CAT SIJ Fixation System)Tenon Medical, Inc.201830—
+6K172517SeaSpine Navigation SystemSeaSpine Orthopedics Corporation2018601
+6K172166OLYMPIC Navigated InstrumentsAstura Medical20185—
+6K172115Navigated Instrument SystemOrthofix, Inc.20184—
+6K172518Spineology Navigation InstrumentsSpineology, Inc.20184—
+6K172623NuVasive Navigation InstrumentsNu Vasive, Incorporated20176—
+6K172275Vitality® Spinal Fixation System, Vitality®+ Power Instrument SystemZimmer Biomet Spine, Inc.20170—
+6K171807ES2 Neuromonitoring Accessory InstrumentsStryker Corporation20177—
+6K171267NavLock TrackersMedtronic Navigation201741
+6K170312IPC systems, Legend EHS handpieces and Legend Stylus Touch handpiece, Microsaw…Medtronic Powered Surgical Solutions201711—
+6K162921Navigated Instrument SystemOrthofix, Inc.20175—
+6K153587Taps for Resorbable ScrewsSynthes (USA) Products, LLC20170—
+6K161014NuVasive® Reline® SystemNu Vasive, Incorporated201648—
+6K153603Alphatec Navigation InstrumentsAlphatec Spine, Inc.201679—
+6K153203Navigation InstrumentsGlobus Medical, Inc.2016112—
+6K150231Navigated Disc Prep Instruments and CAPSTONE TrialsMedtronic Sofamor Danek USA, Inc.2015242—
+6K142438Nerve Monitoring Cable SystemPioneer Surgical Technology, Inc. (Rti Surgical, Inc.)20154—
+6K143375CD HORIZON Spinal System, Medtronic Navigated Reusable InstrumentsMedtronic Sofamor Danek USA, Inc.2015207—
+6K143628Navigated Vertex Select InstrumentsMedtronic Sofamor Danek USA, Inc.2015206—
+6K132694Nuvasive NVM5 SystemNu Vasive, Incorporated201424—
+6K131425Navigated Capstone Trials, Clydesdale Trials, Capstone & Clydesdale InserterMedtronic Navigation, Inc.201324610
+7K262193RIVA® Posterior Fixation System with NanoACTIV Surface Technology; RIVA® Anchor…Xenix Medical20260—
+7K254174Surgical Power SystemGuizhou Zirui Technology Co., Ltd.20260—
+7K262121Ion-L Navigated InstrumentsSurGenTec, LLC20260—
+7K253802KHEIRON® Spinal Fixation System, including patient specific K-RODS.M.A.I.O20261—
+7K260989Varion Thoracolumbar Fixation SystemKyocera Medical Technologies Inc. (KMTI)20260—
+7K252542LEO Spinal SystemZheJiang Decans Medical Devices Co., Ltd.20260—
+7K260216CD Horizon™ ModuLeX™ Fenestrated Screw Set; CD Horizon™ ModuLeX™ Spinal SystemMedtronic Sofamor Danek USA, Inc.20260—
+7K260011Foundation Surgical Navigated Lateral Disc Prep InstrumentsFoundation Surgical Group, Inc.20260—
+7K254158SPINEART Navigation Instrument SystemSpineart SA20261—
+7K260477CATAMARAN™ SI Joint Fusion SystemTenon Medical20260—
+7K253488iFuse INTRA Ti™ Implant SystemSI-BONE, Inc.20260—
+7K252842SafeOp 3: Neural Informatix SystemAlphatec Spine, Inc.202601
+7K253941CD Horizon™ ModuLeX™ Spinal System (LigaMAS Head Assembly)Medtronic Sofamor Danek USA, Inc.20260—
+7K252088Firebird SI Navigation SystemOrthofix US, LLC20251—
+7K252346OLYMPIC Posterior Spinal Fixation System; MASADA Modular Spinal Fixation SystemAstura Medical20250—
+7K253331PressON Spinal Fixation SystemNexus Spine20250—
+7K250894Eminent Spine Posterior SI SystemEminent Spine20250—
+7K252437JAZZ Spinal SystemImplanet20250—
+7K251073Innovasis Navigation Instruments (Vector G-E Navigation Instruments and the Excella G-E…Innovasis, Inc.202501
+7K250908Virata Spinal Fixation SystemSeaSpine Orthopedics Corporation202521
+7K242933SPINEART Navigation Instrument SystemSpineart SA20252—
+7K242464Stealth™ Spine Clamps; ModuLeX™ Shank MountsMedtronic Navigation, Inc.20251—
+7K250403Catamaran SI Joint Fusion SystemTenon Medical20251—
+7K243565DYNAMIS™ SI Screw SystemPromethean Restorative, LLC20251—
+7K243259MASADA Modular Spinal Fixation SystemAstura Medical20250—
+7K243106CarboClear® Hybrid Pedicle Screw SystemCarboFix Orthopedics, Ltd.20240—
+7K242350Spinal Alignment Solutions Pelvic Incidence (PI) Rod SystemSpinal Alignment Solutions, Inc.20241—
+7K241895Cannulated PsiFGuardSpineguard20240—
+7K241813SI-TECHNOLOGY® SI-DESIS® X™ Sacroiliac Joint Fusion SystemSi-Technology, LLC20241—
+7K241644SPINEART Navigation Instrument SystemSpineart SA20243—
+7K233793CarboClear® X Pedicle Screw SystemCarboFix Orthopedics, Ltd.20241—
+7K233256Robotic Integration InstrumentsDePuy Synthes20240—
+7K233255CROSSNAV Navigation Enabled InstrumentsDePuy Synthes20242—
+7K241082INNOVERSE Navigation InstrumentsInnosys Co., Ltd.20240—
+7K240963Spinal SystemTeslake, Inc.20240—
+7K241276Vector™ Pedicle Screw SystemInnovasis, Inc.202411
+7K240392JAZZ Spinal SystemImplanet20241—
+7K240625CORUS Navigation Access SystemProvidence Medical Technology, Inc.20244—
+7K232149BowTie™ SI Joint Fusion SystemSail Fusion, LLC20242—
+7K232259Patriot-SI Posterior Implant SystemSpinal Simplicity, LLC20241—
+7K233989CarboClear® Posterior Cervical Screw SystemCarboFix Orthopedics, Ltd.20242—
+7K233508iFuse Bedrock Granite® Implant SystemSI-BONE, Inc.20245—
+7K233944CarboClear® X Pedicle Screw System; CarboClear® X Navigated InstrumentsCarboFix Orthopedics, Ltd.20243—
+7K231923Liberty SI Lateral Implant SystemSpinal Simplicity, LLC20230—
+7K231694MASADA Modular Spinal Fixation SystemAstura Medical20232—