510(k) Report

Devices descending from K811452

205 later devices reach Brown-Roberts-Wells Stereotaxic Sytem through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+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—