510(k) Report

Devices descending from K954989

589 later devices reach Dyonics Disposable Endoscopic Surgery Blades through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+5K110097Acclarent Cyclops Multi-Angle EndoscopeAcclarent, Inc.20113—
+5K103741Surgisure Tissue Removal SystemInterlace Medical, Inc.20110—
+5K100638Vapr Vue Radiofrequency System ,Model 225024, VPR Vue Wireless Footswitch, Model 227214Depuy Mitek, A Johnson & Johnson Company20108—
+5K100410Piezoelectric SystemSatelec20108—
+5K100559Myosure Hysteroscopic Tissue Removal SystemInterlace Medical, Inc.20106—
+5K081475Electric Drill System [XPS 4000 System, Midas Rex Legend Ehs System, Integrated Power…Medtronic Xomed, Inc.20084433
+5K081277XPS 4000 System, Midas Rex Legend Ehs System, Integrated Power CONS0LE (Ipc)Medtronic Xomed, Inc.20084201
+5K022986The Bioplate Battery Powered DrillBioplate, Inc.20020—
+6K254174Surgical Power SystemGuizhou Zirui Technology Co., Ltd.20260—
+6K260984HERizon RD5 Resecting Device (5FR1PK);HERizon RD5 Resecting Device - 5 pack (5FR5PK)Axora Medical, Inc.20260—
+6K243020MIDASVuIntravu, Inc.20241—
+6K233958hekaDrillZethon, Ltd.20240—
+6K233115Hawkeye Control Unit with Eyas EndoscopeE Surgical, LLC20240—
+6K212556mi-eye 3 needlescope with cannula, mi-tablet 3Trice Medical, Inc.20210—
+6K193630hekaDrillZethon, Ltd.20210—
+6K191597Stealth Autoguide System, Midas Rex Legend Depth Stop SystemMedtronic Navigation, Inc.201941
+6K191177LENS 4K Camera Control Unit - Wifi, LENS 4K Camera Control Unit - Non-Wifi, LENS 4K…Smith and Nephew, Inc.20191—
+6K191345Pegasus SystemA.M. Surgical, Inc.20190—
+6K190367Smith & Nephew Tablet ApplicationSmith & Nephew20193—
+6K183515MR8 Drill System, Midas Rex MR8 ClearView ToolsMedtronic Powered Surgical Solutions20194—
+6K181974MyoSure XL Tissue Removal Device for FluentHologic, Inc.20181—
+6K180825Fluent Fluid Management SystemHologic, Inc.20182—
+6K172464XD880A Ultrasonic Osteotomy Surgical SystemMorley Research Consortium20182—
+6K173740Reprocessed DePuy Mitek Ablation WandRenovo, Inc.20180—
+6K163610PIEZOTOME M+, PIEZOTOME M+ HandpieceSatalec-Acteon Group20170—
+6K163565MR8 Drill SystemMedtronic Powered Surgical Solutions20177—
+6K160713Stealth-Midas SystemMedtronic Powered Surgical Solutions20169—
+6K153743Piezosurgery PlusMectron S.P.A.20162—
+6K152777Bovie Disposable Bipolar AblatorBovie Medical Corporation201632
+6K150728XPS Nexus System, XPS Nexus Foot Control, XPS Nexus IV PoleMedtronic Xomed, Inc.20150—
+6K143475VAPR Tripolar Suction ElectrodeDepuy Mitek201501
+6K141122Harmonic Scallop Blade, Generator G11Ethicon Endo-Surgery, LLC20149—
+6K140896Vapr Arctic Suction ElectrodeDepuy Mitek, A Johnson & Johnson Company20140—
+6K130755Hicut Highspeed InstrumentAdeor Medical AG20144—
+6K132433Acclarent Cyclops Multi-Angle EndoscopeAcclarent, Inc.20141—
+6K132264PRIMADO2 Total Surgical SystemNakanishi, Inc.20136—
+6K133061Espin SystemNlt Spine, Ltd.20130—
+6K131581Myosure Tissue Removal Device (1 Pack and 3 Pack)Hologic, Inc.20130—
+6K122498Myosure XL Tissue Removal Device (1 Pack) Myosure XL Tissue Removal Device (3 Pack)Hologic, Inc.20121—
+6K121264Triton Electric High Torque Handpiece and Software ModuleMedtronic Surgical Technologies201212—
+6K121868Myosure Lite Tissue Removal Device (1 Pack), Myosure Lite Tissue Removal Device (3 Pack)Hologic, Inc.20120—
+6K120095Side Effect with Hand Controls, Hook Electrode with Hand Controls, 2.3 Wedge Electrode…Depuy Mitek, A Johnson & Johnson Company20120—
+6K120593Myosure Control UnitHologic, Inc.20120—
+6K111520Ipc Powerease SystemMedtronic Xomed, Inc.20114182
+7K252579Orthoscan TAU MVP Mini C-Arm SystemZiehm-Orthoscan, Inc.20260—
+7K243280Piezomed Pro (Piezomed Pro module M-PM100 incl. handpiece M-PH350, Piezomed Pro…W&H Dentalwerk Buermoos GmbH20250—
+7K243698Alignment System Cranial, with Alignment Software Cranial with LITT; Cirq Alignment…Brainlab AG20250—
+7K240886Fluent Pro Fluid Management System (FLT-200); Fluent Pro Fluid Management System…Hologic, Inc.20240—
+7K233638VERZA™ High Speed DrillsGlobus Medical, Inc.20241—
+7K233710Symphion Operative Hysteroscopy SystemMinerva Surgical, Inc.20240—
+7K232684Surgify HaloSurgify Medical OY20233—
+7K223864Alignment System Cranial, Alignment Software Cranial, Cirq Alignment Software Cranial…Brainlab AG20231—
+7K231126Eblator DeviceE Surgical, LLC20231—
+7K221740Smith & Nephew Intellio 4K Camera Control Unit, Network Enabled (72205447), Smith &…Smith and Nephew, Inc.20220—
+7K220241“POINT” Kinguide Robotic-Assisted Surgical SystemPoint Robotics MedTech, Inc.20224—
+7K212614Ultrasonic Scalpel SystemSurgnova Healthcare Technologies (Zhejiang) Co., Ltd.20221—
+7K213221AMADEO, M-UK1015 (incl. attachments and accessories)W&H Dentalwerk Buermoss GmbH20221—
+7K213454Midas Rex MR8 Depth Stop Attachment, Midas Rex MR8 Depth Stop Tool 2.4mm, Midas Rex MR8…Medtronic Powered Surgical Solutions20210—
+7K210989Cirq, Cirq Robotic Alignment System, Cirq Robotic Alignment Module Cranial, Cirq Robotic…Brainlab AG20212—
+7K202120P300 AttachmentNakanishi, Inc.20211—
+7K210637CD Horizon™ Spinal SystemMedtronic202134—
+7K201274Ultrasonic Osteotomy Surgical SystemSmtp Technology Co., Ltd.20210—
+7K202552Midas Rex Attachments and Dissecting ToolsMedtronic Powered Surgical Solutions (Mpss)20200—
+7K201407CD Horizon™ Spinal SystemMedtronic Sofamor Danek USA, Inc.202054—
+7K192033Contour P-Insert 90, Contour P-Insert 45, Contour P-Insert Tri Tip, Contour P-Insert WC…Bennett Jacoby, Dds, Ms, Inc.20200—
+7K192876INTELLIO Tablet ApplicationSmith & Nephew20202—
+7K190281Ultrasonic Surgical SystemMedisonic Technology CO20190—
+7K183644Stealth-Midas MR8 SystemMedtronic Powered Surgical Solutions20193—
+7K182436POWEREASE SystemMedtronic Sofamor Danek USA, Inc.20180—
+7K170679CD HORIZON® Spinal System, Medtronic Reusable Instruments for Use with the IPC®…Medtronic Sofamor Danek201786—
+7K153701ULYSS Multi View SinuscopeSopro-Comeg GmbH20160—
+7K160554Enseal X1 Large Jaw Tissue SealerEthicon Endo-Surgery, LLC20166—
+7K161210RIALTO (TM) SI Fusion System, Medtronic Reusable Instruments for Use with the IPC (TM)…Medtronic Sofamor Danek201679—
+7K161558Bovie 3.3mm Disposable Bipolar Ablator 90°, Aspirating and Non-Aspirating, Bovie 2.4mm…Bovie Medical Corporation201623
+7K153442CD HORIZON Spinal System, Medtronic Navigated Manual Reusable Instruments for Use with…Medtronic Sofamor Danek USA, Inc.201684—
+7K153463CD HORIZON Spinal System, IPC POWEREASE SystemMedtronic Sofamor Danek USA, Inc.201587—
+7K143019CD HORIZON Spinal System, IPC POWEREASE SystemMedtronic Sofamor Danek USA, Inc.201588—
+7K140454Navigated CD Horizon Solera Screwdriver/TapsMedtronic Sofamor Danek USA, Inc.20143961
+7K131736Myosure Tissue Removal Device (1 Pack), Myosure Tissue Removal Device (3 Pack)Hologic, Inc.20130—
+7K124004Navigated CD Horizon Solera Screwdrivers, Taps, Iliac Taps, Legacy TapsMedtronic Navigation, Inc.20134041
+7K123270Powerease SystemMedtronic Sofamor Danek USA, Inc.2013398—
+8K262067iFuse Granite Onyx™ Implant SystemSI-BONE, Inc.20260—
+8K261284Invictus® Small Stature Spinal Fixation System; Invictus® 2.0 Spinal Fixation SystemAlphatec Spine, Inc.20260—
+8K260571SIMPACT Sacroiliac Joint Fixation System GX Navigation InstrumentsLife Spine, Inc.20260—
+8K261060Navigated LLIF Impactable TrackerTyber Medical, LLC20260—
+8K260329Ion-C Navigation InstrumentsSurGenTec, LLC20261—
+8K253604TiLink-L Navigation InstrumentsSurGenTec, LLC20260—
+8K253444EUROPA™ Posterior Cervical Fusion Navigated InstrumentsMiRus, LLC20260—
+8K252597Valence Robotic Navigation System; Valence Robotic Navigation Instruments (For Use with…Alphatec Spine, Inc.20261—
+8K252087Navigation Module of the Cortium® SystemUlrich Medical USA, Inc.20260—
+8K254165Infinity™ OCT SystemMedtronic Sofamor Danek USA, Inc.20260—
+8K252962DYNAMIS™ Navigation SystemPromethean Restorative, LLC20260—
+8K250520OsteoCentric Navigated Instruments SystemOsteocentric Technologies, Inc.20250—
+8K253335CD Horizon™ Spinal SystemMedtronic Sofamor Danek USA, Inc.20250—
+8K252322SIros-X SystemGenesys Spine20250—
+8K251899E BlatorNew Deantronics Taiwan, Ltd.20250—
+8K252662UniBurNakanishi, Inc.20250—
+8K250167Evolution Spine Navigation InstrumentsEvolution Spine20250—
+8K250247panaSIa SI Fusion SystemWenzel Spine, Inc.20250—
+8K251395The Rialto™ SI Fusion SystemMedtronic Sofamor Danek USA, Inc.20251—