510(k) Report

Devices descending from K002008

18 later devices reach Surgical Dynamics Spinal Retractor through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K062038X-Sten Mild Tool Kit, Model MTK-0001X-Sten Corp.200614—
+1K003740Miaspas Minitta Anterior Micro Surgical Transthoracic Approach InstrumentationAesculap, Inc.20012—
+2K180610Geister retractor for neuro - and spine surgeryGeister Medizin Technik GmbH20181—
+2K093062Vertos Medical Mild Device KitX-Sten Corp.201013—
+3K252995Durashield Device KitSurGenTec, LLC20260—
+3K233800Vertos mild Device Kit (MDK-0002)Vertos Medical, Inc.20243—
+3K212636CORUS Spinal System-XProvidence Medical Technology, Inc.20215—
+3K180876DTRAX Spinal SystemProvidence Medical Technology, Inc.20187—
+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—
+4K190201CORUS Spinal SystemProvidence Medical Technology, Inc.20196—
+5K260329Ion-C Navigation InstrumentsSurGenTec, LLC20261—
+5K252546VantageTM Lumbar Decompression KitAllevion Medical, LLC20260—
+5K243659FLASH™ Facet Fusion Instruments, IsoTis® Facet Fusion InstrumentsSeaSpine Orthopedics Corporation20250—
+6K262121Ion-L Navigated InstrumentsSurGenTec, LLC20260—