510(k) Report

Devices descending from K040424

18 later devices reach Laser Endoscopic Decompression Kit, Model 1100, and Percutaneous Discectomy… through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K040919Nucleotome Probe Set, Model 21200Clarus Medical, LLC2004171
+2K092877Indiscal Aspiration Device and AccessoriesBaylis Medical Co., Inc.20090—
+2K090303Xtend-ST Nucleus Removal System, Model 9004Corespine Technologies, LLC20090—
+2K062038X-Sten Mild Tool Kit, Model MTK-0001X-Sten Corp.200614—
+3K093062Vertos Medical Mild Device KitX-Sten Corp.201013—
+4K233800Vertos mild Device Kit (MDK-0002)Vertos Medical, Inc.20243—
+4K212636CORUS Spinal System-XProvidence Medical Technology, Inc.20215—
+4K180876DTRAX Spinal SystemProvidence Medical Technology, Inc.20187—
+4K122662Vertiflex Direct Decompression SystemVertiflex, Inc.20120—
+5K253523Freedom DS™ Decompression SystemSpinal Simplicity20260—
+5K243774ELID (Endoscopic Less Invasive Decompression) SystemLesspine Innovations20251—
+5K251060CORUS™ Navigation System-GXProvidence Medical Technology, Inc.20250—
+5K240625CORUS Navigation Access SystemProvidence Medical Technology, Inc.20244—
+5K190201CORUS Spinal SystemProvidence Medical Technology, Inc.20196—
+6K260329Ion-C Navigation InstrumentsSurGenTec, LLC20261—
+6K252546VantageTM Lumbar Decompression KitAllevion Medical, LLC20260—
+6K243659FLASH™ Facet Fusion Instruments, IsoTis® Facet Fusion InstrumentsSeaSpine Orthopedics Corporation20250—
+7K262121Ion-L Navigated InstrumentsSurGenTec, LLC20260—