510(k) Report

Devices descending from K010811

72 later devices reach Perc-D Spinewand through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K132797L'DISQU&I Corporation20141—
+1K100353Spinewand Surgical DeviceArthrocare Corp.20103—
+1K081051Spinevu Endoscopic Spine System (Sess), Spinevu MiniscopeSpine View, Inc.200816—
+1K032473Dekompressor Percutaneous Discectomy ProbeStryker Instruments2003283
+1K020621Arthrocare Controller; Arthrocare Cable; Foot Control; Power Cord; WandsArthrocare Corp.200233—
+2K180315DiskomBiopsybell S.R.L.20180—
+2K162490Disc-FX SystemElliquence, LLC20170—
+2K150915Spinaut-PImedicom Co., Ltd.20160—
+2K141557Herniatome Percutaneous Disectomy Device - Cervical, Herniatome Percutaneous Disectomy…Gallini Medical Devices, Srl201413
+2K132099Arthrocare Coblator IQ DLR Spinewand, Arthrocare Coblator IQ DLG SpinewandArthroCare Corporation20131—
+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—
+2K090278Enspire Debrider SystemSpine View, Inc.20097—
+2K062038X-Sten Mild Tool Kit, Model MTK-0001X-Sten Corp.200614—
+2K040919Nucleotome Probe Set, Model 21200Clarus Medical, LLC2004171
+2K030954Arthrocare Percd SpinewandArthrocare Corp.200332—
+3K181292PrimeSight™ UNITY 9000 Video Processor, PrimeSight™ UNITY 9100 Video ProcessorCogentix Medical, Inc.20180—
+3K150248ORL Video NasoPharyngo-LarngoscopeJedmed Instrument Company20150—
+3K150776Medrobotics Flex SystemMedrobotics Corporation20151—
+3K123359OVS1 Video SystemOlive Medical Corp.20121—
+3K121548Spinevu Endoscopic Spine System (Sess)Spine View, Inc.20120—
+3K110992Enspire Debrider SystemSpine View, Inc.20116—
+3K093062Vertos Medical Mild Device KitX-Sten Corp.201013—
+3K092877Indiscal Aspiration Device and AccessoriesBaylis Medical Co., Inc.20090—
+3K090303Xtend-ST Nucleus Removal System, Model 9004Corespine Technologies, LLC20090—
+3K053447Arthrocare Perc-D SpinewandArthrocare Corp.20056—
+3K040338Arthrocare Controller, Cable, Foot Control, Power Cord, Wands, Models H0970-02…Arthrocare Corp.200424—
+4K233800Vertos mild Device Kit (MDK-0002)Vertos Medical, Inc.20243—
+4K212636CORUS Spinal System-XProvidence Medical Technology, Inc.20215—
+4K180876DTRAX Spinal SystemProvidence Medical Technology, Inc.20187—
+4K170453Medrobotics Flex Robotic SystemMedrobotics Corporation20170—
+4K1525138X-10-XXXX Camera SystemSanta Barbara Imaging Systems20150—
+4K122662Vertiflex Direct Decompression SystemVertiflex, Inc.20120—
+4K120553ESPINNlt Spine, Ltd.20122—
+4K120680Enspire Discectomy SystemSpine View, Inc.20120—
+4K071963Modification to: Arthrocare ArthrowandsArthrocare Corp.200721—
+4K070351Space 360 Delivery SystemDfine, Inc.20071—
+4K061259Modification to Arthrocare Perc-D SpinewandArthrocare Corp.20062—
+5K253523Freedom DS™ Decompression SystemSpinal Simplicity20260—
+5K243774ELID (Endoscopic Less Invasive Decompression) SystemLesspine Innovations20251—
+5K251060CORUS™ Navigation System-GXProvidence Medical Technology, Inc.20250—
+5K240625CORUS Navigation Access SystemProvidence Medical Technology, Inc.20244—
+5K190201CORUS Spinal SystemProvidence Medical Technology, Inc.20196—
+5K173741Reprocessed ArthoCare Ablation WandRenovo, Inc.20180—
+5K133061Espin SystemNlt Spine, Ltd.20130—
+5K130057ESPINNlt Spine, Ltd.20131—
+5K090986Stabili Erx Bone Cement, Model 1135,Stabilit Vertebral Augmentation System (for Use W/…Dfine, Inc.20090—
+5K072865Modificaton to: Arthrocare ArthrowandsArthrocare Corp.200720—
+6K260329Ion-C Navigation InstrumentsSurGenTec, LLC20261—
+6K252546VantageTM Lumbar Decompression KitAllevion Medical, LLC20260—
+6K243659FLASH™ Facet Fusion Instruments, IsoTis® Facet Fusion InstrumentsSeaSpine Orthopedics Corporation20250—
+6K082323Arthrocare ArthrowandsArthrocare Corp.200819—
+7K262121Ion-L Navigated InstrumentsSurGenTec, LLC20260—
+7K083281EL Lightwave Suction Ablator, Model EL-2000-S, Lightwave Suction Ablator, Model…Linvatec Corp.20090—
+7K082980Arthrocare ArthrowandsArthrocare Corp.20081712
+8K090393Arthrocare System 15000 Contoller, Model 72202149, Arthrocare Arthrowands, Model…Arthrocare Corp.20091—
+8K083306Modification to Arthrocare ArthrowandsArthrocare Corp.2008141
+9K180848AMBIENT Super MULTIVAC 50 Wand with Integrated Finger SwitchesArthroCare Corporation20180—
+9K171324Medline ReNewal Reprocessed ArthroCare ArthroWands and Smith & Nephew DyonicsSurgical Instrument Service and Savings, Inc.20170—
+9K162126Ambient KVac Wand with Integrated Finger Switches (Ambient KVac IFS), KVac Integrated…ArthroCare Corporation20160—
+9K161558Bovie 3.3mm Disposable Bipolar Ablator 90°, Aspirating and Non-Aspirating, Bovie 2.4mm…Bovie Medical Corporation201623
+9K152777Bovie Disposable Bipolar AblatorBovie Medical Corporation201632
+9K143235RF20000a Controller, FLOW 50 WandArthroCare Corporation20154—
+9K120791Ambient Turboflash 90 IfsArthocare Corporation20124—
+9K093165Arthrocare System 15000 Controller, ArthrowandsArthrocare Corp.20090—
+10K231126Eblator DeviceE Surgical, LLC20231—
+10K162074Werewolf RF20000 Controller, FLOW 50 WandArthroCare Corporation20163—
+11K251899E BlatorNew Deantronics Taiwan, Ltd.20250—
+11K183346FLOW 90 WandArthroCare Corporation20192—
+12K240964FLOW 90? WandArthroCare Corporation20241—
+13K254122FLOW FLEXTEND Wand (72290039)ArthroCare Corporation20260—