510(k) Report

Devices descending from K043602

29 later devices reach Quadrant Retractor System through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K151104Otelo LLSpineart20160—
+1K113273Spotlight Access SystemJohnson & Johnson20120—
+1K090070Invuity Britefield Mcculloch Retractor SystemInvuity, Inc.20090—
+1K062038X-Sten Mild Tool Kit, Model MTK-0001X-Sten Corp.200614—
+1K060973Vycor Surgical Access SystemsVycor Medical, LLC200610Class I
+2K202694Vycor Medical Viewsite Brain Access System (“VBAS”) and VBAS with Alignment Clip (“VBAS…Vycor Medical, Inc.20210—
+2K120691Brain PortNico Corporation201282
+2K093062Vertos Medical Mild Device KitX-Sten Corp.201013—
+3K233800Vertos mild Device Kit (MDK-0002)Vertos Medical, Inc.20243—
+3K212636CORUS Spinal System-XProvidence Medical Technology, Inc.20215—
+3K182211Aurora Surgiscope SystemRebound Therapeutics Corporation20194—
+3K180876DTRAX Spinal SystemProvidence Medical Technology, Inc.20187—
+3K150378NICO BrainPath & Accessories, NICO BrainPath, NICO Shepherd's HookNico Corporation20152—
+3K122662Vertiflex Direct Decompression SystemVertiflex, Inc.20120—
+4K253523Freedom DS™ Decompression SystemSpinal Simplicity20260—
+4K243774ELID (Endoscopic Less Invasive Decompression) SystemLesspine Innovations20251—
+4K251060CORUS™ Navigation System-GXProvidence Medical Technology, Inc.20250—
+4K240625CORUS Navigation Access SystemProvidence Medical Technology, Inc.20244—
+4K191861Aurora Surgiscope SystemRebound Therapeutics20193—
+4K190201CORUS Spinal SystemProvidence Medical Technology, Inc.20196—
+4K172433NICO BrainPathNico Corporation20171—
+5K260329Ion-C Navigation InstrumentsSurGenTec, LLC20261—
+5K252546VantageTM Lumbar Decompression KitAllevion Medical, LLC20260—
+5K243659FLASH™ Facet Fusion Instruments, IsoTis® Facet Fusion InstrumentsSeaSpine Orthopedics Corporation20250—
+5K201840Aurora Surgiscope System (Surgiscope), Aurora Surgiscope System (Image Control Box)Rebound Therapeutics202021
+5K202072MindsEye Expandable PortMinnetronix Neuro, Inc.20200—
+6K262121Ion-L Navigated InstrumentsSurGenTec, LLC20260—
+6K250752AURORA® Surgiscope® System (ASX15/60); AURORA® Surgiscope® System (ASX15/80)Integra LifeSciences Corporation20250—
+6K232618Aurora Surgiscope SystemRebound Therapeutics Corporation202301