510(k) Report

Devices descending from K002053

427 later devices reach Navitrak System-Optical Option, Model 900.004 through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+13K253591Phantom® Hindfoot TTC/TC Nail SystemParagon 28, Inc.20260—
+13K250667DeGen Medical Patient Specific Implant (PSI) SystemDegen Medical20251—
+13K243481TMINI Miniature Robotic SystemTHINK Surgical, Inc.20255—
+13K231314Fine Osteotomy™Bodycad Laboratories, Inc.20232—
+13K230064Mazor X System (Mazor X Stealth Edition)Mazor Robotics, Ltd.202332
+13K212537Real Intelligence Cori (Cori)Blue Belt Technologies, Inc.202112—
+13K210869Phantom Hindfoot TTC/TC Nail SystemParagon 28, Inc.202123
+13K211441Navigated Anterolateral Disc Prep InstrumentsMedtronic Sofamor Danek USA, Inc.20219—
+14K260011Foundation Surgical Navigated Lateral Disc Prep InstrumentsFoundation Surgical Group, Inc.20260—
+14K251829DeGen Medical Patient Specific Implant (PSI) SystemDegen Medical20250—
+14K251316Mazor X System / Mazor X Stealth EditionMazor Robotics, Ltd.20251—
+14K250877TMINI Miniature Robotic SystemTHINK Surgical, Inc.20254—
+14K240625CORUS Navigation Access SystemProvidence Medical Technology, Inc.20244—
+14K240066Fine Osteotomy™Bodycad Laboratories, Inc.20241—
+14K232345ATEC Posterior Navigated Disc Prep InstrumentsAlphatec Spine, Inc.20232—
+14K230716Robotic Graft Delivery InstrumentsMedtronic Sofamor Danek, Inc.20230—
+14K220255Real Intelligence CoriBlue Belt Technologies, Inc.202211—
+15K260329Ion-C Navigation InstrumentsSurGenTec, LLC20261—
+15K253381Stealth AXiS™ Surgical System with Stealth AXiS™ Spine clinical applicationMedtronic Navigation, Inc.20260—
+15K252544TMINI Miniature Robotic SystemTHINK Surgical, Inc.20253—
+15K243659FLASH™ Facet Fusion Instruments, IsoTis® Facet Fusion InstrumentsSeaSpine Orthopedics Corporation20250—
+15K240703Fine Osteotomy™Bodycad Laboratories, Inc.20240—
+15K220958Real Intelligence CoriBlue Belt Technologies, Inc.20220—
+16K262121Ion-L Navigated InstrumentsSurGenTec, LLC20260—
+16K253661TMINI Miniature Robotic SystemTHINK Surgical, Inc.20252—
+17K260010TMINI® Miniature Robotic SystemTHINK Surgical, Inc.202611
+18K261024TMINI Miniature Robotic SystemTHINK Surgical, Inc.202601