510(k) Report

Devices descending from K842956

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

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+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—
+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—
+9K223708Entasis 3D Dual-Lead Sacroiliac Implant SystemCorelink, LLC20233—
+9K223819SI-Cure Sacroiliac Joint Fusion SystemAlevio, LLC20232—
+9K223181NuVasive Reline SystemNu Vasive, Incorporated202311—
+9K223649VERTICALE® Navigation InstrumentsSilony Medical GmbH20223—
+9K222516Mercury® II Spinal SystemSpinal Elements, Inc.20223—
+9K203503Camber Sacroiliac (SI) Fixation SystemCamber Spine Technologies, LLC20222—
+9K211496TransLoc 3DFoundation Fusion Solutions, LLC (Dba Cornerloc)20227—
+9K220131KYPHON VuE Bone CementTecres S.P.A.20220—
+9K212962TRELLIS™ SI Joint Fusion SystemOrthofundamentals, LLC20220—
+9K220724CD Horizon™ Spinal System and PASS LP™ Spinal SystemMedicrea International20221—
+9K213918DeGen Navigated InstrumentationDegen Medical20220—
+9K214059CoreLink Navigation InstrumentsCorelink, LLC20220—
+9K213720Vital Navigation SystemZimvie (Zimmer Biomet Spine, Inc.)20220—
+9K213281PASS LP™ Spinal System, CD Horizon™ Spinal SystemMedicrea International SA20220—
+9K212489BonOs Inject Bone Cement; NEO Pedicle Screw SystemNeo Medical SA20215—
+9K210402Curiteva Sacroiliac Joint Fusion SystemCuriteva, Inc.20212—
+9K211442StealthStation Spinous Process ClampsMedtronic Navigation20212—
+9K211596CD Horizon Spinal SystemMedtronic20213—
+9K211441Navigated Anterolateral Disc Prep InstrumentsMedtronic Sofamor Danek USA, Inc.20219—
+9K211323ASTRA Spine SystemSpinecraft, LLC202112—
+9K211057LigaPASS® Spinal System, CD Horizon™ Spinal SystemMedtronic, Inc.20211—
+9K210425Catalyft PL Expandable Interbody SystemMedtronic Sofamor Danek USA, Inc.2021561
+9K210306GII Spinal Fixation SystemColigne AG20210—
+9K202458BonOs Inject, Pedicle screw kits, Cement pusherOsartis GmbH20216—
+9K210472SPINEART Navigation Instrument SystemSpineart20215—
+9K203247iFuse-TORQ™ Implant SystemSI-BONE, Inc.2021171
+9K203153CREO Stabilization System, Navigation Instruments, ExcelsiusGPSGlobus Medical, Inc.20211—
+9K203561ChoiceSpine Navigation SystemChoice Spine, LLC20211—
+9K200719NuVasive Navigation.S InstrumentsNu Vasive, Incorporated20204—
+9K201006K2M Navigation InstrumentsK2m, Inc.20200—
+9K201327NavLock TrackersMedtronic Navigation20202—
+9K193011CD Horizon™ Fenestrated Screw SetMedtronic Sofamor Danek USA, Inc.202041—
+9K192336Navigated Anterolateral Disc Prep InstrumentsMedtronic Sofamor Danek USA, Inc.201917—
+9K191597Stealth Autoguide System, Midas Rex Legend Depth Stop SystemMedtronic Navigation, Inc.201941
+9K192526Spine Wave Navigated InstrumentsSpine Wave, Inc.20190—
+9K191039Navigated T2 STRATOSPHERE Inserters and Navigated TemplatesMedtronic Sofamor Danek USA, Inc.201918—
+9K191648Mariner MIS Pedicle Screw System; SeaSpine Navigation SystemSeaSpine Orthopedics Corporation201949—
+9K190163ALARA Neuro Access KitSurGenTec, LLC20192—
+9K183515MR8 Drill System, Midas Rex MR8 ClearView ToolsMedtronic Powered Surgical Solutions20194—
+9K182721Choice Spine Navigation SystemChoicespine, LP20192—
+9K182104NavLock Trackers, Robotic Reference FrameMedtronic Navigation201831
+9K182345Spineology Navigation InstrumentsSpineology, Inc.20182—
+9K181068CREO® Stabilization System, REVERE® Stabilization SystemGlobus Medical, Inc.20182—
+9K180690Navigation InstrumentsGlobus Medical, Inc.20189—
+9K181111Navigated INFINITY InstrumentsMedtronic Sofamor Danek USA, Inc.20182—
+9K180796Spineology Navigation InstrumentsSpineology, Inc.20183—
+9K180198NuVasive® VuePoint® II OCT SystemNu Vasive, Incorporated20184—
+9K173338Navigated INFINITY™ InstrumentsMedtronic Sofamor Danek USA, Inc.201815—
+9K171894NuVasive® Precept™ Spinal SystemNu Vasive, Incorporated20170—
+9K171321K2M Navigation InstrumentsK2m201711
+9K163581Navigated ELEVATE Inserter, Navigated Disc Prep InstrumentsMedtronic Sofamor Danek USA, Inc.2017103—
+9K170126NuVasive® Reline® 4.5-5.0 SystemNu Vasive, Incorporated201739—
+9K161591QUARTEX™ Occipito-Cervico-Thoracic Spinal System, Globus Navigation InstrumentsGlobus Medical, Inc.201678—
+9K160713Stealth-Midas SystemMedtronic Powered Surgical Solutions20169—
+9K152248CD HORIZON Spinal SystemMedtronic Sofamor Danek USA, Inc.20150—
+9K141968Nuvasive NVM5 SystemNuvasive, Inc.201423—
+10K263172SAS MIS Pelvic Incidence RodsSpinal Alignment Solutions, Inc.20260—
+10K262828KHEIRON® Spinal Fixation System, including patient specific K-RODS.M.A.I.O20260—
+10K261205SPINEART Navigation Instrument SystemSpineart SA20260—
+10K253921VERTICALE® Navigation InstrumentsSilony Medical GmbH20260—
+10K261374LigaPASS™ SystemMedicrea International S.A.S20260—
+10K253739SCRIPT™ Rods, CREO™ Stabilization System, REVERE® Stabilization System, REVERE® 4.5…Globus Medical, Inc.20260—
+10K254274ARx® SAI Implant SystemLife Spine, Inc.20260—
+10K260786KHEIRON® Spinal Fixation System, including patient specific K-RODS.M.A.I.O20261—
+10K254045CarboClear® Posterior Cervical Screw System; CarboClear® Hybrid Posterior Cervical Screw…CarboFix Orthopedics, Ltd.20260—
+10K252989“POINT” Kinguide Agile Hybrid Navigation System; DRF Accessories SetPoint Robotics MedTech, Inc.20260—
+10K252327CMORE® CT System; CMORE® CT System Navigated InstrumentsIcotec AG20251—
+10K252742Navigated InstrumentsTyber Medical, LLC20251—
+10K253129Infinity™ OCT SystemMedtronic Sofamor Danek USA, Inc.20250—
+10K253094iFuse Bedrock Granite Implant SystemSI-BONE, Inc.20250—
+10K251060CORUS™ Navigation System-GXProvidence Medical Technology, Inc.20250—
+10K242431Omnia Medical PsiF DNA™ SystemOmnia Medical, LLC20251—
+10K251525SI-TECHNOLOGY® SI-DESIS® X™ Sacroiliac Joint Fusion SystemSi-Technology, LLC20250—
+10K250001Patriot SI Implant SystemSpinal Simplicity, LLC20250—