510(k) Report

Devices descending from K153660

144 later devices reach StealthStation System with Cranial Software through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+5K261882Pisces-SC Standalone Cervical Interbody SystemOsseus Fusions Systems, LLC20260—
+5K262094E3D™-C Interbody SystemEvolution Spine20260—
+5K260036NeckTune™ 3D SA Cervical CageMedyssey Co, Ltd.20260—
+5K253379Stealth AXiS Cranial clinical applicationMedtronic Navigation, Inc.20260—
+5K254045CarboClear® Posterior Cervical Screw System; CarboClear® Hybrid Posterior Cervical Screw…CarboFix Orthopedics, Ltd.20260—
+5K254105Hive™ Standalone Cervical System and Hive™ C Interbody SystemNanoHive Medical, LLC20260—
+5K260038E3D™-C Interbody SystemEvolution Spine20261—
+5K252894aprevo® cervical interbody systemCarlsmed, Inc.20261—
+5K252054SpineAR SNAP (SyncAR Spine)Surgical Theater, Inc.20250—
+5K250108OptiVu™ ShoulderMr Surgical Solutions, LLC20251—
+5K243802aprevo® anterior and lateral lumbar interbody fusion device, aprevo® anterior lumbar…Carlsmed, Inc.20253—
+5K241327Navient Image Guide Navigation System (955-NC-NC), CranialClaronav20250—
+5K241481xvision Spine SystemAugmedics, Ltd.20243—
+5K240326Solar™ Lumbar Interbody Fusion SystemDegen Medical, Inc.20244—
+5K232176STELLAR KneePolarisar, Inc.20230—
+5K232280NextAR™ TSA PlatformMedacta International S.A.20231—
+5K231284OnPoint Augmented Reality Spine SystemOnpoint Surgical, Inc.20231—
+5K230789Knee+Pixee Medical20235—
+5K230064Mazor X System (Mazor X Stealth Edition)Mazor Robotics, Ltd.202332
+5K223438TELIGEN System Peripheral Motor Nerve Stimulation IndicationsMedos International SARL20230—
+5K211441Navigated Anterolateral Disc Prep InstrumentsMedtronic Sofamor Danek USA, Inc.20219—
+6K260385aprevo® anterior and lateral lumbar interbody system; aprevo® posterior and…Carlsmed, Inc.20260—
+6K260011Foundation Surgical Navigated Lateral Disc Prep InstrumentsFoundation Surgical Group, Inc.20260—
+6K251316Mazor X System / Mazor X Stealth EditionMazor Robotics, Ltd.20251—
+6K252170OptiVu™ ShoulderMr Surgical Solutions, LLC20250—
+6K250827aprevo® anterior lumbar interbody fusion device; aprevo® lateral lumbar interbody fusion…Carlsmed, Inc.20252—
+6K250255xvision Spine systemAugmedics, Ltd.20252—
+6K241077DeGen Medical Patient Specific Implant (PSI) SystemDegen Medical20242—
+6K241870OnPoint Augmented Reality Spine SystemOnpoint Surgical, Inc.20240—
+6K240625CORUS Navigation Access SystemProvidence Medical Technology, Inc.20244—
+6K233899Knee+Pixee Medical20244—
+6K232345ATEC Posterior Navigated Disc Prep InstrumentsAlphatec Spine, Inc.20232—
+6K230716Robotic Graft Delivery InstrumentsMedtronic Sofamor Danek, Inc.20230—
+7K260329Ion-C Navigation InstrumentsSurGenTec, LLC20261—
+7K252597Valence Robotic Navigation System; Valence Robotic Navigation Instruments (For Use with…Alphatec Spine, Inc.20261—
+7K251639xvision Spine systemAugmedics, Ltd.20251—
+7K250667DeGen Medical Patient Specific Implant (PSI) SystemDegen Medical20251—
+7K243659FLASH™ Facet Fusion Instruments, IsoTis® Facet Fusion InstrumentsSeaSpine Orthopedics Corporation20250—
+7K243975Knee+Pixee Medical20253—
+8K261854xvision Spine systemAugmedics, Ltd.20260—
+8K262121Ion-L Navigated InstrumentsSurGenTec, LLC20260—
+8K261284Invictus® Small Stature Spinal Fixation System; Invictus® 2.0 Spinal Fixation SystemAlphatec Spine, Inc.20260—
+8K253805Knee+Pixee Medical S.A.S.20260—
+8K251829DeGen Medical Patient Specific Implant (PSI) SystemDegen Medical20250—