510(k) Report

Devices descending from K922881

21 later devices reach Clarus Models 1100, 1101, 1102, 1103 Laser Disc through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K040424Laser Endoscopic Decompression Kit, Model 1100, and Percutaneous Discectomy Kit, Model…Clarus Medical, LLC2004181
+1K022610Clarus Straight Firing Laser Fiber, Model 1150, Clarus Side Firing Laser Fiber, Model 1160Clarus Medical, LLC200219—
+1K021848Clarus Straight Firing Laser Fiber; Clarus Side Firing Laser Fiber; Models 1150, 1160Clarus Medical, LLC20020—
+2K040919Nucleotome Probe Set, Model 21200Clarus Medical, LLC2004171
+3K092877Indiscal Aspiration Device and AccessoriesBaylis Medical Co., Inc.20090—
+3K090303Xtend-ST Nucleus Removal System, Model 9004Corespine Technologies, LLC20090—
+3K062038X-Sten Mild Tool Kit, Model MTK-0001X-Sten Corp.200614—
+4K093062Vertos Medical Mild Device KitX-Sten Corp.201013—
+5K233800Vertos mild Device Kit (MDK-0002)Vertos Medical, Inc.20243—
+5K212636CORUS Spinal System-XProvidence Medical Technology, Inc.20215—
+5K180876DTRAX Spinal SystemProvidence Medical Technology, Inc.20187—
+5K122662Vertiflex Direct Decompression SystemVertiflex, Inc.20120—
+6K253523Freedom DS™ Decompression SystemSpinal Simplicity20260—
+6K243774ELID (Endoscopic Less Invasive Decompression) SystemLesspine Innovations20251—
+6K251060CORUS™ Navigation System-GXProvidence Medical Technology, Inc.20250—
+6K240625CORUS Navigation Access SystemProvidence Medical Technology, Inc.20244—
+6K190201CORUS Spinal SystemProvidence Medical Technology, Inc.20196—
+7K260329Ion-C Navigation InstrumentsSurGenTec, LLC20261—
+7K252546VantageTM Lumbar Decompression KitAllevion Medical, LLC20260—
+7K243659FLASH™ Facet Fusion Instruments, IsoTis® Facet Fusion InstrumentsSeaSpine Orthopedics Corporation20250—
+8K262121Ion-L Navigated InstrumentsSurGenTec, LLC20260—