510(k) Report

Devices descending from K170011

126 later devices reach StealthStation S8 Spine Software v1.0.0 through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+4K223438TELIGEN System Peripheral Motor Nerve Stimulation IndicationsMedos International SARL20230—
+4K211441Navigated Anterolateral Disc Prep InstrumentsMedtronic Sofamor Danek USA, Inc.20219—
+5K260385aprevo® anterior and lateral lumbar interbody system; aprevo® posterior and…Carlsmed, Inc.20260—
+5K260011Foundation Surgical Navigated Lateral Disc Prep InstrumentsFoundation Surgical Group, Inc.20260—
+5K254045CarboClear® Posterior Cervical Screw System; CarboClear® Hybrid Posterior Cervical Screw…CarboFix Orthopedics, Ltd.20260—
+5K251316Mazor X System / Mazor X Stealth EditionMazor Robotics, Ltd.20251—
+5K252170OptiVu™ ShoulderMr Surgical Solutions, LLC20250—
+5K250827aprevo® anterior lumbar interbody fusion device; aprevo® lateral lumbar interbody fusion…Carlsmed, Inc.20252—
+5K250255xvision Spine systemAugmedics, Ltd.20252—
+5K241077DeGen Medical Patient Specific Implant (PSI) SystemDegen Medical20242—
+5K241870OnPoint Augmented Reality Spine SystemOnpoint Surgical, Inc.20240—
+5K240625CORUS Navigation Access SystemProvidence Medical Technology, Inc.20244—
+5K233899Knee+Pixee Medical20244—
+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—
+6K251639xvision Spine systemAugmedics, Ltd.20251—
+6K250667DeGen Medical Patient Specific Implant (PSI) SystemDegen Medical20251—
+6K243659FLASH™ Facet Fusion Instruments, IsoTis® Facet Fusion InstrumentsSeaSpine Orthopedics Corporation20250—
+6K243975Knee+Pixee Medical20253—
+7K261854xvision Spine systemAugmedics, Ltd.20260—
+7K262121Ion-L Navigated InstrumentsSurGenTec, LLC20260—
+7K261284Invictus® Small Stature Spinal Fixation System; Invictus® 2.0 Spinal Fixation SystemAlphatec Spine, Inc.20260—
+7K253805Knee+Pixee Medical S.A.S.20260—
+7K251829DeGen Medical Patient Specific Implant (PSI) SystemDegen Medical20250—