510(k) Report

Devices descending from K052241

38 later devices reach Disc-FX System through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K162490Disc-FX SystemElliquence, LLC20170—
+1K130110Meddusa Bipolar SystemElliquence, LLC20134—
+1K081051Spinevu Endoscopic Spine System (Sess), Spinevu MiniscopeSpine View, Inc.200816—
+1K062038X-Sten Mild Tool Kit, Model MTK-0001X-Sten Corp.200614—
+2K190336Soniquence Bipolar ElectrodesSoniquence, LLC20193—
+2K122134Flexlite CameraSpine View, Inc.20120—
+2K113362Spinevu Endoscopic Spine System (Sess)Spine View, Inc.20121—
+2K102733Vision-Sciences Ent-5000 Video Ent Scope with Endosheath Technology, Vision-Sciences…Vision-Sciences, Inc.20117—
+2K093062Vertos Medical Mild Device KitX-Sten Corp.201013—
+2K090278Enspire Debrider SystemSpine View, Inc.20097—
+3K233800Vertos mild Device Kit (MDK-0002)Vertos Medical, Inc.20243—
+3K212636CORUS Spinal System-XProvidence Medical Technology, Inc.20215—
+3K211946Soniquence Reusable Bipolar CableSoniquence, LLC20210—
+3K202558Ellusa Bipolar WandsEllusa, LLC20201—
+3K181292PrimeSight™ UNITY 9000 Video Processor, PrimeSight™ UNITY 9100 Video ProcessorCogentix Medical, Inc.20180—
+3K180876DTRAX Spinal SystemProvidence Medical Technology, Inc.20187—
+3K150248ORL Video NasoPharyngo-LarngoscopeJedmed Instrument Company20150—
+3K150776Medrobotics Flex SystemMedrobotics Corporation20151—
+3K123359OVS1 Video SystemOlive Medical Corp.20121—
+3K122662Vertiflex Direct Decompression SystemVertiflex, Inc.20120—
+3K121548Spinevu Endoscopic Spine System (Sess)Spine View, Inc.20120—
+3K110992Enspire Debrider SystemSpine View, Inc.20116—
+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—
+4K222429Ellusa Reusable Bipolar CableEllusa, LLC20220—
+4K190201CORUS Spinal SystemProvidence Medical Technology, Inc.20196—
+4K170453Medrobotics Flex Robotic SystemMedrobotics Corporation20170—
+4K1525138X-10-XXXX Camera SystemSanta Barbara Imaging Systems20150—
+4K120553ESPINNlt Spine, Ltd.20122—
+4K120680Enspire Discectomy SystemSpine View, Inc.20120—
+5K260329Ion-C Navigation InstrumentsSurGenTec, LLC20261—
+5K252546VantageTM Lumbar Decompression KitAllevion Medical, LLC20260—
+5K243659FLASH™ Facet Fusion Instruments, IsoTis® Facet Fusion InstrumentsSeaSpine Orthopedics Corporation20250—
+5K133061Espin SystemNlt Spine, Ltd.20130—
+5K130057ESPINNlt Spine, Ltd.20131—
+6K262121Ion-L Navigated InstrumentsSurGenTec, LLC20260—