510(k) Report

Devices descending from K002931

82 later devices reach Metrx System through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K243774ELID (Endoscopic Less Invasive Decompression) SystemLesspine Innovations20251—
+1K181885Voyant SystemViseon, Inc.20182—
+1K161878PORTAGE SystemBaylis Medical Company, Inc.20160—
+1K082293Surgview Integrated Visualization SystemBiovision Technologies, LLC200821—
+1K072879Innervue Diagnostic Scope SystemBiomet Orthopedics, Inc.2008302
+1K062038X-Sten Mild Tool Kit, Model MTK-0001X-Sten Corp.200614—
+1K043602Quadrant Retractor SystemMedtronic Sofamor Danek200529—
+1K022199Endius Atavi SystemEndius, Inc.200243—
+2K252546VantageTM Lumbar Decompression KitAllevion Medical, LLC20260—
+2K191579Voyant SystemViseon, Inc.20191—
+2K151104Otelo LLSpineart20160—
+2K143705NeedleCam HD Visualization SystemBiovision Technologies, LLC20152—
+2K141326Needle View CH Scope KitsBiovision Technologies, LLC20143—
+2K123359OVS1 Video SystemOlive Medical Corp.20121—
+2K113273Spotlight Access SystemJohnson & Johnson20120—
+2K102733Vision-Sciences Ent-5000 Video Ent Scope with Endosheath Technology, Vision-Sciences…Vision-Sciences, Inc.20117—
+2K101734Visionscope High Definition Endoscopy Camera System with; Camera Control Unit; Camera…Visionscope Technologies, LLC20107—
+2K093717C-Mor Visualization DeviceAxis Surgical Technologies, Inc.201016—
+2K093062Vertos Medical Mild Device KitX-Sten Corp.201013—
+2K090070Invuity Britefield Mcculloch Retractor SystemInvuity, Inc.20090—
+2K060973Vycor Surgical Access SystemsVycor Medical, LLC200610Class I
+2K061345Modification to Endius Atavi SystemEndius, Inc.2006171
+2K053267Endius Atavi SystemEndius, Inc.2006421
+3K252790Digital ClarusScope System and Digital NeuroPEN SystemClarus Medical, LLC20260—
+3K233800Vertos mild Device Kit (MDK-0002)Vertos Medical, Inc.20243—
+3K213978TELIGEN SystemMedos International SARL20220—
+3K212636CORUS Spinal System-XProvidence Medical Technology, Inc.20215—
+3K202694Vycor Medical Viewsite Brain Access System (“VBAS”) and VBAS with Alignment Clip (“VBAS…Vycor Medical, Inc.20210—
+3K203526C Scope Visualization SystemCit Ortho202102
+3K181292PrimeSight™ UNITY 9000 Video Processor, PrimeSight™ UNITY 9100 Video ProcessorCogentix Medical, Inc.20180—
+3K181982MIDAScope and Introducer Kit, and MIDASystemIntravu, Inc.20182—
+3K180876DTRAX Spinal SystemProvidence Medical Technology, Inc.20187—
+3K153606LENS Camera Control Unit-WiFi, LENS Camera Unit-Non-WiFi, LENS camera head, Camera…Smith & Nephew20166—
+3K1525138X-10-XXXX Camera SystemSanta Barbara Imaging Systems20150—
+3K150248ORL Video NasoPharyngo-LarngoscopeJedmed Instrument Company20150—
+3K150776Medrobotics Flex SystemMedrobotics Corporation20151—
+3K141119Camera Enabled ProbeTrice Medical, Inc.20147—
+3K122134Flexlite CameraSpine View, Inc.20120—
+3K122662Vertiflex Direct Decompression SystemVertiflex, Inc.20120—
+3K120691Brain PortNico Corporation201282
+3K113362Spinevu Endoscopic Spine System (Sess)Spine View, Inc.20121—
+3K081051Spinevu Endoscopic Spine System (Sess), Spinevu MiniscopeSpine View, Inc.200816—
+3K061246Endoscopic Spine SystemArthro Kinetics, Inc.200625—
+4K253523Freedom DS™ Decompression SystemSpinal Simplicity20260—
+4K251060CORUS™ Navigation System-GXProvidence Medical Technology, Inc.20250—
+4K243020MIDASVuIntravu, Inc.20241—
+4K240625CORUS Navigation Access SystemProvidence Medical Technology, Inc.20244—
+4K191177LENS 4K Camera Control Unit - Wifi, LENS 4K Camera Control Unit - Non-Wifi, LENS 4K…Smith and Nephew, Inc.20191—
+4K190367Smith & Nephew Tablet ApplicationSmith & Nephew20193—
+4K190201CORUS Spinal SystemProvidence Medical Technology, Inc.20196—
+4K182211Aurora Surgiscope SystemRebound Therapeutics Corporation20194—
+4K170453Medrobotics Flex Robotic SystemMedrobotics Corporation20170—
+4K162475mi-eye 2, mi-eye 2 monitorTrice Medical20166—
+4K150378NICO BrainPath & Accessories, NICO BrainPath, NICO Shepherd's HookNico Corporation20152—
+4K121261Asap MuitiscopeAsap Endoscopic Products GmbH20130—
+4K121548Spinevu Endoscopic Spine System (Sess)Spine View, Inc.20120—
+4K083552Maxmorespine Tom StickHoogland Spine Products, GmbH20095—
+4K090132Maxmorespine Spinal SystemHoogland Spine Products, GmbH20091—
+4K090278Enspire Debrider SystemSpine View, Inc.20097—
+5K260329Ion-C Navigation InstrumentsSurGenTec, LLC20261—
+5K252579Orthoscan TAU MVP Mini C-Arm SystemZiehm-Orthoscan, Inc.20260—
+5K243659FLASH™ Facet Fusion Instruments, IsoTis® Facet Fusion InstrumentsSeaSpine Orthopedics Corporation20250—
+5K233115Hawkeye Control Unit with Eyas EndoscopeE Surgical, LLC20240—
+5K221740Smith & Nephew Intellio 4K Camera Control Unit, Network Enabled (72205447), Smith &…Smith and Nephew, Inc.20220—
+5K212556mi-eye 3 needlescope with cannula, mi-tablet 3Trice Medical, Inc.20210—
+5K192876INTELLIO Tablet ApplicationSmith & Nephew20202—
+5K191861Aurora Surgiscope SystemRebound Therapeutics20193—
+5K191345Pegasus SystemA.M. Surgical, Inc.20190—
+5K172433NICO BrainPathNico Corporation20171—
+5K121482Instrument System for Endoscopic Spinal SurgeryTheken Spine, LLC20120—
+5K110992Enspire Debrider SystemSpine View, Inc.20116—
+6K262121Ion-L Navigated InstrumentsSurGenTec, LLC20260—
+6K203566Tablet ApplicationSmith & Nephew20211—
+6K201840Aurora Surgiscope System (Surgiscope), Aurora Surgiscope System (Image Control Box)Rebound Therapeutics202021
+6K202072MindsEye Expandable PortMinnetronix Neuro, Inc.20200—
+6K120553ESPINNlt Spine, Ltd.20122—
+6K120680Enspire Discectomy SystemSpine View, Inc.20120—
+7K250752AURORA® Surgiscope® System (ASX15/60); AURORA® Surgiscope® System (ASX15/80)Integra LifeSciences Corporation20250—
+7K232618Aurora Surgiscope SystemRebound Therapeutics Corporation202301
+7K221929Smith+Nephew INTELLIO TabletSmith+Nephew20220—
+7K133061Espin SystemNlt Spine, Ltd.20130—
+7K130057ESPINNlt Spine, Ltd.20131—