510(k) Report

Devices descending from K162309

39 later devices reach StealthStation S8 System Platforms and StealthStation Cranial Software through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K253381Stealth AXiS™ Surgical System with Stealth AXiS™ Spine clinical applicationMedtronic Navigation, Inc.20260—
+1K241333Geniant Cranial (Navigated Neurosurgical Positioning Robot)Koh Young Technology, Inc.20251—
+1K241130“POINT” Kinguide Agile Hybrid Navigation System (PSHF01-000)Point Robotics MedTech, Inc.20242—
+1K230087“POINT” Kinguide Agile Hybrid Navigation SystemPoint Robotics MedTech, Inc.20233—
+1K212194Stryker Q Guidance System with Cranial Guidance Software, CranialMask Tracker and…Stryker Corporation202312
+1K220241“POINT” Kinguide Robotic-Assisted Surgical SystemPoint Robotics MedTech, Inc.20224—
+1K200047ExcelsiusGPS Cranial 1.0 ModuleGlobus Medical, Inc.202053
+1K201175StealthStation Cranial Software v1.3.0Medtronic Navigation, Inc.20208—
+1K182077Mazor X System (Mazor X Stealth Edition)Mazor Robotics, Ltd.2018162
+2K253856Geniant Cranial (Navigated Neurosurgical Positioning Robot)Koh Young Technology, Inc.20260—
+2K252989“POINT” Kinguide Agile Hybrid Navigation System; DRF Accessories SetPoint Robotics MedTech, Inc.20260—
+2K252755POINT Kinguide Agile Robotic Arm Surgical Stereotactic SystemPoint Robotics MedTech, Inc.20260—
+2K231850QUARTEX® Occipito-Cervico-Thoracic Spinal System ExcelsiusGPS® InstrumentsGlobus Medical, Inc.20242—
+2K233542Ortho Guidance Precision Knee Software; Ortho Guidance Express Knee Software; Ortho…Stryker Leibinger GmbH & Co KG20240—
+2K213989Cranial EM SystemBrainlab AG20221—
+2K203153CREO Stabilization System, Navigation Instruments, ExcelsiusGPSGlobus Medical, Inc.20211—
+2K203639StealthStation Cranial Software v1.3.2Medtronic Navigation, Inc.20215—
+2K200935Mazor XMazor Robotics, Ltd.202015—
+3K253739SCRIPT™ Rods, CREO™ Stabilization System, REVERE® Stabilization System, REVERE® 4.5…Globus Medical, Inc.20260—
+3K252327CMORE® CT System; CMORE® CT System Navigated InstrumentsIcotec AG20251—
+3K223288Cranial Navigation, Navigation Software Cranial, Navigation Software Craniofacial…Brainlab AG20230—
+3K212397StealthStation S8 Cranial v2.0Medtronic Navigation20214Class I
+3K203005Mazor XMazor Robotics, Ltd.2020141
+4K253379Stealth AXiS Cranial clinical applicationMedtronic Navigation, Inc.20260—
+4K254045CarboClear® Posterior Cervical Screw System; CarboClear® Hybrid Posterior Cervical Screw…CarboFix Orthopedics, Ltd.20260—
+4K241327Navient Image Guide Navigation System (955-NC-NC), CranialClaronav20250—
+4K230064Mazor X System (Mazor X Stealth Edition)Mazor Robotics, Ltd.202332
+4K211441Navigated Anterolateral Disc Prep InstrumentsMedtronic Sofamor Danek USA, Inc.20219—
+5K260011Foundation Surgical Navigated Lateral Disc Prep InstrumentsFoundation Surgical Group, Inc.20260—
+5K251316Mazor X System / Mazor X Stealth EditionMazor Robotics, Ltd.20251—
+5K240625CORUS Navigation Access SystemProvidence Medical Technology, Inc.20244—
+5K232345ATEC Posterior Navigated Disc Prep InstrumentsAlphatec Spine, Inc.20232—
+5K230716Robotic Graft Delivery InstrumentsMedtronic Sofamor Danek, Inc.20230—
+6K260329Ion-C Navigation InstrumentsSurGenTec, LLC20261—
+6K252597Valence Robotic Navigation System; Valence Robotic Navigation Instruments (For Use with…Alphatec Spine, Inc.20261—
+6K251060CORUS™ Navigation System-GXProvidence Medical Technology, Inc.20250—
+6K243659FLASH™ Facet Fusion Instruments, IsoTis® Facet Fusion InstrumentsSeaSpine Orthopedics Corporation20250—
+7K262121Ion-L Navigated InstrumentsSurGenTec, LLC20260—
+7K261284Invictus® Small Stature Spinal Fixation System; Invictus® 2.0 Spinal Fixation SystemAlphatec Spine, Inc.20260—