510(k) Report

Devices descending from K954796

490 later devices reach Micro-Ingressor Handipiece through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+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—
+9K152248CD HORIZON Spinal SystemMedtronic Sofamor Danek USA, Inc.20150—
+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—
+10K253627Surgify Halo (54.085.SHD.U1); Surgify Halo (54.140.SHD. U1); Surgify Halo…Surgify Medical OY2026011
+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—
+10K252755POINT Kinguide Agile Robotic Arm Surgical Stereotactic SystemPoint 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—
+10K251075DYNAMIS™ Implant SystemPromethean Restorative, LLC20250—
+10K243659FLASH™ Facet Fusion Instruments, IsoTis® Facet Fusion InstrumentsSeaSpine Orthopedics Corporation20250—
+10K242890SPINEART Navigation Instrument SystemSpineart SA20253—
+10K243916Primus Spinal Fixation SystemSpinal Elements, Inc.20252—
+10K242297Reform Pedicle Screw SystemPrecision Spine, Inc.20240—
+10K241893CROSSNAV Navigation Enabled Instruments and UNAS Navigation ArraysMedos International SARL20241—
+10K241504iFuse TORQ TNT™ Implant SystemSI-BONE, Inc.20240—
+10K241464ARx® SAI Implant SystemLife Spine, Inc.20241—
+10K241519Invictus® Small Stature Spinal Fixation SystemAlphatec Spine, Inc.20242—
+10K240505Eminent Spine SI Screw SystemEminent Spine, LLC20241—
+10K240720TiLink-P SI Joint Fusion SystemSurGenTec, LLC20243—
+10K231850QUARTEX® Occipito-Cervico-Thoracic Spinal System ExcelsiusGPS® InstrumentsGlobus Medical, Inc.20242—
+10K233455ARx MIS Spinal Screw SystemLife Spine, Inc.20230—
+10K232345ATEC Posterior Navigated Disc Prep InstrumentsAlphatec Spine, Inc.20232—
+10K232878TransLoc 3DFoundation Fusion Solutions, LLC (Dba Cornerloc)20230—
+10K232650KHEIRON® Spinal Fixation System, including patient specific K-RODS.M.A.I.O20236—
+10K232605Sacrix® Sacroiliac Joint Fusion Device System, Inspan® ScrewLES Fusion System, Invue®…Lesspine Innovations20230—
+10K231931Adena-Zina Spinal SystemShanghai Sanyou Medical Co, Ltd.20230—
+10K231951SI-Cure Sacroiliac Joint Fusion SystemAlevio, LLC20231—
+10K231689iFuse TORQ® Implant SystemSI-BONE, Inc.20235—
+10K230861VADER® Pedicle System Navigated InstrumentsIcotec AG20230—
+10K230774PERLA® TL System; TEKTONA® HV US Bone CementSpineart20230—
+10K223765ATEC Lateral Navigation InstrumentsAlphatec Spine, Inc.202302
+10K223273ASTRA Spine SystemSpinecraft, LLC20228—
+10K213196MARVEL™ Growing RodsGlobus Medical, Inc.20220—
+10K222605iFuse TORQ® Implant SystemSI-BONE, Inc.202214—
+10K222256BonOs® Inject Bone Cement; NEO Pedicle Screw System™Neo Medical SA20223—
+10K221776NextGen Pedicle Screw SystemCorelink, LLC20222—
+10K213876Spineology Navigation InstrumentsSpineology, Inc.20221—
+10K213667iFuse-TORQ® Implant SystemSI-BONE, Inc.202215—
+10K213654NuVasive Reline Cervical SystemNu Vasive, Incorporated20221—
+10K214011Catalyft™ PL Expandable Interbody System Navigated Instruments, Anteralign™ TL Spinal…Medtronic Sofamor Danek USA, Inc.20221—
+10K212524Anteralign Spinal System with Titan nanoLOCK Surface TechnologyMedtronic Sofamor Danek USA, Inc.202155—
+10K212023Virage Navigation SystemZimmer Biomet Spine, Inc.20211—
+10K211957QUARTEX Occipito-Cervico-Thoracic Spinal System, Globus Navigation InstrumentsGlobus Medical, Inc.20213—
+10K211993Z-LINKPC SystemZavation Medical Products, LLC20210—
+10K210574NuVasive Pulse SystemNu Vasive, Incorporated202121
+10K211606Mariner Deformity SystemSeaSpine Orthopedics Corporation2021471
+10K200936Invictus™ CT Spinal Fixation SystemAlphatec Spine, Inc.20203—
+10K190636NuVasive® Reline® 4.5-5.0 SystemNu Vasive, Incorporated201913—
+10K191553NuVaisve® Reline® Cervical SystemNu Vasive, Incorporated20192—
+10K191100ExcelsiusGPS Spine 1.1 Interbody ModuleGlobus Medical, Inc.201942—
+10K190360LineSider™ Spinal SystemIntegrity Implants, Inc.201913—
+10K182974NuVasive Reline SystemNu Vasive, Incorporated201911—
+10K182000AQrate Robotic Assistance SystemGlobus Medical, Inc.20191—
+10K171651Excelsius GPSGlobus Medical, Inc.2017691
+10K162266The Cranial Fusion SystemLife Spine, Inc.20171—
+11K261020Symmetrix™ L Spinal SystemMedtronic Sofamor Danek USA, Inc.20260—
+11K261665CORUS™ Navigation System-GNProvidence Medical Technology, Inc.20260—
+11K254157CROSSNAV Navigation Enabled Instruments for Disc Preparation and InterbodyMedos International SARL20260—
+11K253615Invictus Bands SystemAlphatec Spine, Inc.20260—
+11K254148VERTICALE GPS InstrumentsSilony Medical GmbH20260—
+11K252834Sacroiliac Joint Truss System (SJTS)4Web Medical20260—
+11K253990KHEIRON® Spinal Fixation System, including patient specific K-RODS.M.A.I.O20262—
+11K253721KHEIRON® Spinal Fixation System, including patient specific K-RODS.M.A.I.O20252—
+11K253093Vital™ Spinal Fixation SystemHighridge Medical, LLC20250—
+11K251943Spineology Navigation InstrumentsSpineology, Inc.20250—
+11K250599ExcelsiusGPS™ InstrumentsGlobus Medical, Inc.20250—
+11K242827A8 INTEGR8™ Porous Pedicle ScrewsAllumin8, Inc.20251—
+11K251780iGPS Navigation InstrumentsSI-BONE, Inc.20250—
+11K241525ExcelsiusXR™Globus Medical, Inc.20250—
+11K251804KHEIRON® Spinal Fixation System, including patient specific K-RODS.M.A.I.O20254—
+11K251719Momentum® Posterior Spinal Fixation SystemUlrich Medical USA, Inc.20250—
+11K243326Dynamis Robotic Surgical SystemLEM Surgical AG20251—
+11K243514Salvo® Robotic Navigation InstrumentsSpine Wave, Inc.20250—
+11K243814NuVasive Pulse SystemGlobus Medical, Inc.20250—
+11K243693NEO Pedicle Screw System™Neo Medical SA20240—
+11K243671ExcelsiusGPS® InstrumentsGlobus Medical, Inc.20240—
+11K242414TiLink-P Joint Fusion SystemSurGenTec, LLC20240—
+11K240160EGPS Navigated InstrumentsAstura Medical20240—
+11K242141TiLink-P SI Joint Fusion SystemSurGenTec, LLC20241—
+11K241574iFuse TORQ® Implant SystemSI-BONE, Inc.20244—
+11K240721ExcelsiusFlex™Globus Medical, Inc.20240—
+11K233228Spine Navigation and Robotic-Assistance DeviceEcential Robotics202421
+11K240951Invictus Robotic Navigation InstrumentsAlphatec Spine20242—