510(k) Report

Devices descending from K842956

481 later devices reach Nicolet Viking through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+8K223301ASTRA & AVANT Navigation Instruments System and ASTRA-OCT Navigation Instruments SystemSpinecraft, LLC20230—
+8K223808Zavation Navigation Instrument SystemZavation Medical Products, LLC20230—
+8K230369EUROPA™ Navigated InstrumentsMiRus, LLC20230—
+8K223511Excella Navigation InstrumentsInnovasis, Inc.20233—
+8K230880CoreLink Navigation InstrumentsCorelink, LLC20230—
+8K223494CD Horizon Spinal SystemMedtronic202317—
+8K223200Curiteva Navigation SystemCuriteva, Inc.20230—
+8K221646CD HORIZON™ ASTUTE™ SPINAL SYSTEM; CD HORIZON™ Growth Rod Conversion Set; CD HORIZON™…Medtronic Sofamor Danek USA, Inc.202220—
+8K221047SILO TFX MIS Sacroiliac Joint Fixation SystemAurora Spine, Inc.20229—
+8K220024ChoiceSpine Navigation SystemChoice Spine, LLC20220—
+8K220973CoreLink Navigation InstrumentsCorelink, LLC20221—
+8K221244CD Horizon™ Spinal SystemMedtronic202220—
+8K213491Universal Pilot Guidance Instrument SystemCtl Medical Corporation20220—
+8K220038Camber Spine Navigation SystemCamber Spine Technologies20220—
+8K220291NEXXT SPINE NAVIGATION SystemNexxt Spine, LLC20220—
+8K212088Integrity Implants Navigated InstrumentsIntegrity Implants, Inc.20210—
+8K212903SIMPACT Sacroiliac Joint Fixation SystemLife Spine, Inc.20218—
+8K212825CoreLink Navigation InstrumentsCorelink, LLC20214—
+8K212028Dark Star Navigation Instrument SystemRepublic Spine, LLC20210—
+8K202836GX Navigation Instrument SystemLife Spine, Inc.20211—
+8K212007VERTICALE Navigation InstrumentsSilony Medical GmbH20214—
+8K211958CD Horizon Spinal SystemMedtronic Sofamor Danek USA, Inc.202115—
+8K210716CarboClear X Pedicle Screw System, CarboClear X Navigated InstrumentsCarboFix Orthopedics, Ltd.20218—
+8K203816DeGen Navigated InstrumentationDegen Medical20211—
+8K203780Harvester SI: Sacroiliac Fixation SystemSpinus International, Inc.20210—
+8K202956Erisma LP Navigated InstrumentsClariance, Sas20210—
+8K203573RESPONSE Navigation InstrumentsOrthoPediatrics Corp.20210—
+8K203291CD Horizon Spinal System InstrumentsMedtronic Sofamor Danek USA, Inc.202035—
+8K202771CD Horizon Spinal SystemMedtronic202021—
+8K200845Navigation Module of the Momentum SystemUlrich Medical USA20200—
+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—
+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—
+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—
+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—