510(k) Report

Devices descending from K830332

16 later devices reach Budde-Halo Retractor through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K093054Scalp Dura Retractor, Model KS00474KARL STORZ Endoscopy-America, Inc.20100—
+1K060973Vycor Surgical Access SystemsVycor Medical, LLC200610Class I
+1K060097Grossman Self-Retaining Low Profile Brain Retractor, Model 04-001-00KLS-Martin L.P.20063—
+1K991267Spine Applications for the Mayfield/Acciss Operating Arm and Optical Acciss Systems…Ohio Medical Instrument Co., Inc.19990—
+2K202694Vycor Medical Viewsite Brain Access System (“VBAS”) and VBAS with Alignment Clip (“VBAS…Vycor Medical, Inc.20210—
+2K180610Geister retractor for neuro - and spine surgeryGeister Medizin Technik GmbH20181—
+2K120691Brain PortNico Corporation201282
+3K252995Durashield Device KitSurGenTec, LLC20260—
+3K182211Aurora Surgiscope SystemRebound Therapeutics Corporation20194—
+3K150378NICO BrainPath & Accessories, NICO BrainPath, NICO Shepherd's HookNico Corporation20152—
+4K191861Aurora Surgiscope SystemRebound Therapeutics20193—
+4K172433NICO BrainPathNico Corporation20171—
+5K201840Aurora Surgiscope System (Surgiscope), Aurora Surgiscope System (Image Control Box)Rebound Therapeutics202021
+5K202072MindsEye Expandable PortMinnetronix Neuro, Inc.20200—
+6K250752AURORA® Surgiscope® System (ASX15/60); AURORA® Surgiscope® System (ASX15/80)Integra LifeSciences Corporation20250—
+6K232618Aurora Surgiscope SystemRebound Therapeutics Corporation202301