510(k) Report

Devices descending from K011454

40 later devices reach Spine Scope, Model 2180 through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K082841Spinal ForaminoscopeBlazejewski Medi-Tech GmbH200920—
+1K040919Nucleotome Probe Set, Model 21200Clarus Medical, LLC2004171
+1K040424Laser Endoscopic Decompression Kit, Model 1100, and Percutaneous Discectomy Kit, Model…Clarus Medical, LLC2004181
+2K141326Needle View CH Scope KitsBiovision Technologies, LLC20143—
+2K130778Discoscopes, Cervical EndoscopesRz Medizintechnik GmbH201414—
+2K123330Iogyn EndoscopeIogyn, Inc.20130—
+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—
+3K243602Arthrex Spine EndoscopeArthrex, Inc.20250—
+3K181982MIDAScope and Introducer Kit, and MIDASystemIntravu, Inc.20182—
+3K180766Endiscope, Endiscope CervicalElliquence, LLC201812—
+3K093062Vertos Medical Mild Device KitX-Sten Corp.201013—
+4K243020MIDASVuIntravu, Inc.20241—
+4K233800Vertos mild Device Kit (MDK-0002)Vertos Medical, Inc.20243—
+4K212636CORUS Spinal System-XProvidence Medical Technology, Inc.20215—
+4K201134Arthrex NanoScope SystemArthrex, Inc.202011—
+4K180876DTRAX Spinal SystemProvidence Medical Technology, Inc.20187—
+4K122662Vertiflex Direct Decompression SystemVertiflex, Inc.20120—
+5K260414“Tech-Image” Video Endoscope SystemTech-Image CO., LTD.20260—
+5K253523Freedom DS™ Decompression SystemSpinal Simplicity20260—
+5K252579Orthoscan TAU MVP Mini C-Arm SystemZiehm-Orthoscan, Inc.20260—
+5K253217MiiS Horus Arthroscope (EJA 100); MiiS Horus Endoscope Display System -Tablet (EDS 500)…Medimaging Integrated Solution, Inc (Miis)20250—
+5K243774ELID (Endoscopic Less Invasive Decompression) SystemLesspine Innovations20251—
+5K241990SpineSite Endoscope SystemHydrocision, Inc.20250—
+5K251060CORUS™ Navigation System-GXProvidence Medical Technology, Inc.20250—
+5K243008Arthrex NanoScope SystemArthrex, Inc.20254—
+5K240625CORUS Navigation Access SystemProvidence Medical Technology, Inc.20244—
+5K223759Arthrex SynergyID Endoscopic Imaging SystemArthex, Inc.20234—
+5K190201CORUS Spinal SystemProvidence Medical Technology, Inc.20196—
+6K260329Ion-C Navigation InstrumentsSurGenTec, LLC20261—
+6K252546VantageTM Lumbar Decompression KitAllevion Medical, LLC20260—
+6K252640VereSee Optical Veres Needle and Endoscopic CameraFreyja Healthcare, LLC20251—
+6K250728Arthrex Synergy Vision Endoscopic Imaging SystemArthrex, Inc.20251—
+6K243659FLASH™ Facet Fusion Instruments, IsoTis® Facet Fusion InstrumentsSeaSpine Orthopedics Corporation20250—
+6K233451Arthrex Synergy Vision Endoscopic Imaging SystemArthrex, Inc.20243—
+7K261139VereSee (VER150, VER200, VER151, VER201, VER200C, and VER-100-103)Freyja Healthcare, LLC20260—
+7K262121Ion-L Navigated InstrumentsSurGenTec, LLC20260—
+7K251994Arthrex Synergy Vision Imaging SystemArthrex, Inc.20250—
+7K241361Arthrex Synergy Vision Endoscopic Imaging SystemArthrex, Inc.20242—