510(k) Report

Devices descending from K955026

459 later devices reach AS/3 NMT Module through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+5K220131KYPHON VuE Bone CementTecres S.P.A.20220—
+5K212962TRELLIS™ SI Joint Fusion SystemOrthofundamentals, LLC20220—
+5K220724CD Horizon™ Spinal System and PASS LP™ Spinal SystemMedicrea International20221—
+5K213918DeGen Navigated InstrumentationDegen Medical20220—
+5K214059CoreLink Navigation InstrumentsCorelink, LLC20220—
+5K213720Vital Navigation SystemZimvie (Zimmer Biomet Spine, Inc.)20220—
+5K213281PASS LP™ Spinal System, CD Horizon™ Spinal SystemMedicrea International SA20220—
+5K212489BonOs Inject Bone Cement; NEO Pedicle Screw SystemNeo Medical SA20215—
+5K210402Curiteva Sacroiliac Joint Fusion SystemCuriteva, Inc.20212—
+5K211442StealthStation Spinous Process ClampsMedtronic Navigation20212—
+5K211596CD Horizon Spinal SystemMedtronic20213—
+5K211441Navigated Anterolateral Disc Prep InstrumentsMedtronic Sofamor Danek USA, Inc.20219—
+5K211323ASTRA Spine SystemSpinecraft, LLC202112—
+5K211057LigaPASS® Spinal System, CD Horizon™ Spinal SystemMedtronic, Inc.20211—
+5K210425Catalyft PL Expandable Interbody SystemMedtronic Sofamor Danek USA, Inc.2021561
+5K210306GII Spinal Fixation SystemColigne AG20210—
+5K202458BonOs Inject, Pedicle screw kits, Cement pusherOsartis GmbH20216—
+5K210472SPINEART Navigation Instrument SystemSpineart20215—
+5K203247iFuse-TORQ™ Implant SystemSI-BONE, Inc.2021171
+5K203153CREO Stabilization System, Navigation Instruments, ExcelsiusGPSGlobus Medical, Inc.20211—
+5K203561ChoiceSpine Navigation SystemChoice Spine, LLC20211—
+5K200719NuVasive Navigation.S InstrumentsNu Vasive, Incorporated20204—
+5K201006K2M Navigation InstrumentsK2m, Inc.20200—
+5K201327NavLock TrackersMedtronic Navigation20202—
+5K193011CD Horizon™ Fenestrated Screw SetMedtronic Sofamor Danek USA, Inc.202041—
+5K192336Navigated Anterolateral Disc Prep InstrumentsMedtronic Sofamor Danek USA, Inc.201917—
+5K191597Stealth Autoguide System, Midas Rex Legend Depth Stop SystemMedtronic Navigation, Inc.201941
+5K192526Spine Wave Navigated InstrumentsSpine Wave, Inc.20190—
+5K191039Navigated T2 STRATOSPHERE Inserters and Navigated TemplatesMedtronic Sofamor Danek USA, Inc.201918—
+5K191648Mariner MIS Pedicle Screw System; SeaSpine Navigation SystemSeaSpine Orthopedics Corporation201949—
+5K190163ALARA Neuro Access KitSurGenTec, LLC20192—
+5K183515MR8 Drill System, Midas Rex MR8 ClearView ToolsMedtronic Powered Surgical Solutions20194—
+5K182617ATEC IOM Accessory InstrumentsAlphatec Spine, Inc.20193—
+5K182721Choice Spine Navigation SystemChoicespine, LP20192—
+5K182104NavLock Trackers, Robotic Reference FrameMedtronic Navigation201831
+5K182345Spineology Navigation InstrumentsSpineology, Inc.20182—
+5K181068CREO® Stabilization System, REVERE® Stabilization SystemGlobus Medical, Inc.20182—
+5K180038NuVasive Pulse SystemNu Vasive, Incorporated20183—
+5K180690Navigation InstrumentsGlobus Medical, Inc.20189—
+5K181111Navigated INFINITY InstrumentsMedtronic Sofamor Danek USA, Inc.20182—
+5K180796Spineology Navigation InstrumentsSpineology, Inc.20183—
+5K180198NuVasive® VuePoint® II OCT SystemNu Vasive, Incorporated20184—
+5K173338Navigated INFINITY™ InstrumentsMedtronic Sofamor Danek USA, Inc.201815—
+5K171894NuVasive® Precept™ Spinal SystemNu Vasive, Incorporated20170—
+5K171321K2M Navigation InstrumentsK2m201711
+5K163581Navigated ELEVATE Inserter, Navigated Disc Prep InstrumentsMedtronic Sofamor Danek USA, Inc.2017103—
+5K170126NuVasive® Reline® 4.5-5.0 SystemNu Vasive, Incorporated201739—
+5K161591QUARTEX™ Occipito-Cervico-Thoracic Spinal System, Globus Navigation InstrumentsGlobus Medical, Inc.201678—
+5K160713Stealth-Midas SystemMedtronic Powered Surgical Solutions20169—
+5K152248CD HORIZON Spinal SystemMedtronic Sofamor Danek USA, Inc.20150—
+5K141968Nuvasive NVM5 SystemNuvasive, Inc.201423—
+6K263172SAS MIS Pelvic Incidence RodsSpinal Alignment Solutions, Inc.20260—
+6K262828KHEIRON® Spinal Fixation System, including patient specific K-RODS.M.A.I.O20260—
+6K261205SPINEART Navigation Instrument SystemSpineart SA20260—
+6K253921VERTICALE® Navigation InstrumentsSilony Medical GmbH20260—
+6K261374LigaPASS™ SystemMedicrea International S.A.S20260—
+6K253739SCRIPT™ Rods, CREO™ Stabilization System, REVERE® Stabilization System, REVERE® 4.5…Globus Medical, Inc.20260—
+6K254274ARx® SAI Implant SystemLife Spine, Inc.20260—
+6K260786KHEIRON® Spinal Fixation System, including patient specific K-RODS.M.A.I.O20261—
+6K254045CarboClear® Posterior Cervical Screw System; CarboClear® Hybrid Posterior Cervical Screw…CarboFix Orthopedics, Ltd.20260—
+6K252989“POINT” Kinguide Agile Hybrid Navigation System; DRF Accessories SetPoint Robotics MedTech, Inc.20260—
+6K252327CMORE® CT System; CMORE® CT System Navigated InstrumentsIcotec AG20251—
+6K252742Navigated InstrumentsTyber Medical, LLC20251—
+6K253129Infinity™ OCT SystemMedtronic Sofamor Danek USA, Inc.20250—
+6K253094iFuse Bedrock Granite Implant SystemSI-BONE, Inc.20250—
+6K251060CORUS™ Navigation System-GXProvidence Medical Technology, Inc.20250—
+6K242431Omnia Medical PsiF DNA™ SystemOmnia Medical, LLC20251—
+6K251525SI-TECHNOLOGY® SI-DESIS® X™ Sacroiliac Joint Fusion SystemSi-Technology, LLC20250—
+6K250001Patriot SI Implant SystemSpinal Simplicity, LLC20250—
+6K251075DYNAMIS™ Implant SystemPromethean Restorative, LLC20250—
+6K243945ALARA BMA Neuro Access Kit (ALARA BMAN and ALARA BMAC Kit)SurGenTec, LLC20250—
+6K243659FLASH™ Facet Fusion Instruments, IsoTis® Facet Fusion InstrumentsSeaSpine Orthopedics Corporation20250—
+6K242890SPINEART Navigation Instrument SystemSpineart SA20253—
+6K243916Primus Spinal Fixation SystemSpinal Elements, Inc.20252—
+6K243698Alignment System Cranial, with Alignment Software Cranial with LITT; Cirq Alignment…Brainlab AG20250—
+6K242297Reform Pedicle Screw SystemPrecision Spine, Inc.20240—
+6K241893CROSSNAV Navigation Enabled Instruments and UNAS Navigation ArraysMedos International SARL20241—
+6K241504iFuse TORQ TNT™ Implant SystemSI-BONE, Inc.20240—
+6K240664ALARA BMA Neuro Access Kit (ALARA BMAN and ALARA BMAC Kit)SurGenTec, LLC20241—
+6K241464ARx® SAI Implant SystemLife Spine, Inc.20241—
+6K241519Invictus® Small Stature Spinal Fixation SystemAlphatec Spine, Inc.20242—
+6K240505Eminent Spine SI Screw SystemEminent Spine, LLC20241—
+6K240720TiLink-P SI Joint Fusion SystemSurGenTec, LLC20243—
+6K231850QUARTEX® Occipito-Cervico-Thoracic Spinal System ExcelsiusGPS® InstrumentsGlobus Medical, Inc.20242—
+6K233455ARx MIS Spinal Screw SystemLife Spine, Inc.20230—
+6K232345ATEC Posterior Navigated Disc Prep InstrumentsAlphatec Spine, Inc.20232—
+6K232878TransLoc 3DFoundation Fusion Solutions, LLC (Dba Cornerloc)20230—
+6K232650KHEIRON® Spinal Fixation System, including patient specific K-RODS.M.A.I.O20236—
+6K232605Sacrix® Sacroiliac Joint Fusion Device System, Inspan® ScrewLES Fusion System, Invue®…Lesspine Innovations20230—
+6K223864Alignment System Cranial, Alignment Software Cranial, Cirq Alignment Software Cranial…Brainlab AG20231—
+6K231931Adena-Zina Spinal SystemShanghai Sanyou Medical Co, Ltd.20230—
+6K231951SI-Cure Sacroiliac Joint Fusion SystemAlevio, LLC20231—
+6K231689iFuse TORQ® Implant SystemSI-BONE, Inc.20235—
+6K230861VADER® Pedicle System Navigated InstrumentsIcotec AG20230—
+6K230774PERLA® TL System; TEKTONA® HV US Bone CementSpineart20230—
+6K223765ATEC Lateral Navigation InstrumentsAlphatec Spine, Inc.202302
+6K223273ASTRA Spine SystemSpinecraft, LLC20228—
+6K213196MARVEL™ Growing RodsGlobus Medical, Inc.20220—
+6K222605iFuse TORQ® Implant SystemSI-BONE, Inc.202214—
+6K222256BonOs® Inject Bone Cement; NEO Pedicle Screw System™Neo Medical SA20223—