510(k) Report

Devices descending from K871046

214 later devices reach Compass Stereotactic Positioning System through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+13K230064Mazor X System (Mazor X Stealth Edition)Mazor Robotics, Ltd.202332
+13K211441Navigated Anterolateral Disc Prep InstrumentsMedtronic Sofamor Danek USA, Inc.20219—
+14K260011Foundation Surgical Navigated Lateral Disc Prep InstrumentsFoundation Surgical Group, Inc.20260—
+14K253661TMINI Miniature Robotic SystemTHINK Surgical, Inc.20252—
+14K251316Mazor X System / Mazor X Stealth EditionMazor Robotics, Ltd.20251—
+14K240625CORUS Navigation Access SystemProvidence Medical Technology, Inc.20244—
+14K232345ATEC Posterior Navigated Disc Prep InstrumentsAlphatec Spine, Inc.20232—
+14K230716Robotic Graft Delivery InstrumentsMedtronic Sofamor Danek, Inc.20230—
+15K260329Ion-C Navigation InstrumentsSurGenTec, LLC20261—
+15K260010TMINI® Miniature Robotic SystemTHINK Surgical, Inc.202611
+15K253381Stealth AXiS™ Surgical System with Stealth AXiS™ Spine clinical applicationMedtronic Navigation, Inc.20260—
+15K243659FLASH™ Facet Fusion Instruments, IsoTis® Facet Fusion InstrumentsSeaSpine Orthopedics Corporation20250—
+16K261024TMINI Miniature Robotic SystemTHINK Surgical, Inc.202601
+16K262121Ion-L Navigated InstrumentsSurGenTec, LLC20260—