510(k) Report

Devices descending from K862474

478 later devices reach Hall Sternum Saw through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K990524E9000 SystemLinvatec Corp.1999477—
+2K092977Eberle Shaver System AccessoriesEfs Eberle Feinwerktechnische Systeme20101—
+2K083284Piezosurgery MedicalPiezosurgery S.R.L.20099—
+2K083161Zen Wireless Footswitch (W1000), Zen Wireless Footswitch Adapter (W1100)Conmed Linvatec20099—
+2K061134Eberle Shaver System C2 and Shaver BladesEfs Eberle Feinwerktechnische Systeme20062—
+2K060172Rema Shaver BladesRema Medizintechnik GmbH.20060—
+2K052695Suretek Medical Reprocessed Arthroscopic Blades and BursSuretek Medical20060—
+2K012630Reprocessed Linvatec Arthroscopic BursAlliance Medical, Inc.20010—
+2K012613Reprocssed Linvatec ShaversAlliance Medical, Inc.200101
+2K012453Sodem High Speed System (Electric) (General Orthopedics & Plastic Surgery)Sodemsystems2001447—
+2K012457Sodem High Speed System (Electric) (Neuro/Spine Surgery)Sodemsystems2001447—
+2K012456Sodem High Speed System (Electric) (Ear, Nose, and Throat)Sodemsystems2001446—
+3K193608EBERLE Shaver System C3 and AccessoriesEberle GmbH & Co. KG20210—
+3K170312IPC systems, Legend EHS handpieces and Legend Stylus Touch handpiece, Microsaw…Medtronic Powered Surgical Solutions201711—
+3K132848Piezosurgery FlexMectron S.P.A.20136—
+3K100638Vapr Vue Radiofrequency System ,Model 225024, VPR Vue Wireless Footswitch, Model 227214Depuy Mitek, A Johnson & Johnson Company20108—
+3K100410Piezoelectric SystemSatelec20108—
+3K081475Electric Drill System [XPS 4000 System, Midas Rex Legend Ehs System, Integrated Power…Medtronic Xomed, Inc.20084433
+3K081277XPS 4000 System, Midas Rex Legend Ehs System, Integrated Power CONS0LE (Ipc)Medtronic Xomed, Inc.20084201
+3K022986The Bioplate Battery Powered DrillBioplate, Inc.20020—
+4K254174Surgical Power SystemGuizhou Zirui Technology Co., Ltd.20260—
+4K233958hekaDrillZethon, Ltd.20240—
+4K193630hekaDrillZethon, Ltd.20210—
+4K191597Stealth Autoguide System, Midas Rex Legend Depth Stop SystemMedtronic Navigation, Inc.201941
+4K183515MR8 Drill System, Midas Rex MR8 ClearView ToolsMedtronic Powered Surgical Solutions20194—
+4K172464XD880A Ultrasonic Osteotomy Surgical SystemMorley Research Consortium20182—
+4K173740Reprocessed DePuy Mitek Ablation WandRenovo, Inc.20180—
+4K163610PIEZOTOME M+, PIEZOTOME M+ HandpieceSatalec-Acteon Group20170—
+4K163565MR8 Drill SystemMedtronic Powered Surgical Solutions20177—
+4K160713Stealth-Midas SystemMedtronic Powered Surgical Solutions20169—
+4K153743Piezosurgery PlusMectron S.P.A.20162—
+4K152777Bovie Disposable Bipolar AblatorBovie Medical Corporation201632
+4K150728XPS Nexus System, XPS Nexus Foot Control, XPS Nexus IV PoleMedtronic Xomed, Inc.20150—
+4K143475VAPR Tripolar Suction ElectrodeDepuy Mitek201501
+4K141122Harmonic Scallop Blade, Generator G11Ethicon Endo-Surgery, LLC20149—
+4K140896Vapr Arctic Suction ElectrodeDepuy Mitek, A Johnson & Johnson Company20140—
+4K130755Hicut Highspeed InstrumentAdeor Medical AG20144—
+4K132264PRIMADO2 Total Surgical SystemNakanishi, Inc.20136—
+4K133061Espin SystemNlt Spine, Ltd.20130—
+4K121264Triton Electric High Torque Handpiece and Software ModuleMedtronic Surgical Technologies201212—
+4K120095Side Effect with Hand Controls, Hook Electrode with Hand Controls, 2.3 Wedge Electrode…Depuy Mitek, A Johnson & Johnson Company20120—
+4K111520Ipc Powerease SystemMedtronic Xomed, Inc.20114182
+5K243280Piezomed Pro (Piezomed Pro module M-PM100 incl. handpiece M-PH350, Piezomed Pro…W&H Dentalwerk Buermoos GmbH20250—
+5K243698Alignment System Cranial, with Alignment Software Cranial with LITT; Cirq Alignment…Brainlab AG20250—
+5K233638VERZA™ High Speed DrillsGlobus Medical, Inc.20241—
+5K232684Surgify HaloSurgify Medical OY20233—
+5K223864Alignment System Cranial, Alignment Software Cranial, Cirq Alignment Software Cranial…Brainlab AG20231—
+5K231126Eblator DeviceE Surgical, LLC20231—
+5K220241“POINT” Kinguide Robotic-Assisted Surgical SystemPoint Robotics MedTech, Inc.20224—
+5K212614Ultrasonic Scalpel SystemSurgnova Healthcare Technologies (Zhejiang) Co., Ltd.20221—
+5K213221AMADEO, M-UK1015 (incl. attachments and accessories)W&H Dentalwerk Buermoss GmbH20221—
+5K213454Midas Rex MR8 Depth Stop Attachment, Midas Rex MR8 Depth Stop Tool 2.4mm, Midas Rex MR8…Medtronic Powered Surgical Solutions20210—
+5K210989Cirq, Cirq Robotic Alignment System, Cirq Robotic Alignment Module Cranial, Cirq Robotic…Brainlab AG20212—
+5K202120P300 AttachmentNakanishi, Inc.20211—
+5K210637CD Horizon™ Spinal SystemMedtronic202134—
+5K201274Ultrasonic Osteotomy Surgical SystemSmtp Technology Co., Ltd.20210—
+5K202552Midas Rex Attachments and Dissecting ToolsMedtronic Powered Surgical Solutions (Mpss)20200—
+5K201407CD Horizon™ Spinal SystemMedtronic Sofamor Danek USA, Inc.202054—
+5K192033Contour P-Insert 90, Contour P-Insert 45, Contour P-Insert Tri Tip, Contour P-Insert WC…Bennett Jacoby, Dds, Ms, Inc.20200—
+5K190281Ultrasonic Surgical SystemMedisonic Technology CO20190—
+5K183644Stealth-Midas MR8 SystemMedtronic Powered Surgical Solutions20193—
+5K182436POWEREASE SystemMedtronic Sofamor Danek USA, Inc.20180—
+5K170679CD HORIZON® Spinal System, Medtronic Reusable Instruments for Use with the IPC®…Medtronic Sofamor Danek201786—
+5K160554Enseal X1 Large Jaw Tissue SealerEthicon Endo-Surgery, LLC20166—
+5K161210RIALTO (TM) SI Fusion System, Medtronic Reusable Instruments for Use with the IPC (TM)…Medtronic Sofamor Danek201679—
+5K161558Bovie 3.3mm Disposable Bipolar Ablator 90°, Aspirating and Non-Aspirating, Bovie 2.4mm…Bovie Medical Corporation201623
+5K153442CD HORIZON Spinal System, Medtronic Navigated Manual Reusable Instruments for Use with…Medtronic Sofamor Danek USA, Inc.201684—
+5K153463CD HORIZON Spinal System, IPC POWEREASE SystemMedtronic Sofamor Danek USA, Inc.201587—
+5K143019CD HORIZON Spinal System, IPC POWEREASE SystemMedtronic Sofamor Danek USA, Inc.201588—
+5K140454Navigated CD Horizon Solera Screwdriver/TapsMedtronic Sofamor Danek USA, Inc.20143961
+5K124004Navigated CD Horizon Solera Screwdrivers, Taps, Iliac Taps, Legacy TapsMedtronic Navigation, Inc.20134041
+5K123270Powerease SystemMedtronic Sofamor Danek USA, Inc.2013398—
+6K262067iFuse Granite Onyx™ Implant SystemSI-BONE, Inc.20260—
+6K261284Invictus® Small Stature Spinal Fixation System; Invictus® 2.0 Spinal Fixation SystemAlphatec Spine, Inc.20260—
+6K260571SIMPACT Sacroiliac Joint Fixation System GX Navigation InstrumentsLife Spine, Inc.20260—
+6K261060Navigated LLIF Impactable TrackerTyber Medical, LLC20260—
+6K260329Ion-C Navigation InstrumentsSurGenTec, LLC20261—
+6K253604TiLink-L Navigation InstrumentsSurGenTec, LLC20260—
+6K253444EUROPA™ Posterior Cervical Fusion Navigated InstrumentsMiRus, LLC20260—
+6K252597Valence Robotic Navigation System; Valence Robotic Navigation Instruments (For Use with…Alphatec Spine, Inc.20261—
+6K252087Navigation Module of the Cortium® SystemUlrich Medical USA, Inc.20260—
+6K254165Infinity™ OCT SystemMedtronic Sofamor Danek USA, Inc.20260—
+6K252962DYNAMIS™ Navigation SystemPromethean Restorative, LLC20260—
+6K250520OsteoCentric Navigated Instruments SystemOsteocentric Technologies, Inc.20250—
+6K253335CD Horizon™ Spinal SystemMedtronic Sofamor Danek USA, Inc.20250—
+6K252322SIros-X SystemGenesys Spine20250—
+6K251899E BlatorNew Deantronics Taiwan, Ltd.20250—
+6K252662UniBurNakanishi, Inc.20250—
+6K250167Evolution Spine Navigation InstrumentsEvolution Spine20250—
+6K250247panaSIa SI Fusion SystemWenzel Spine, Inc.20250—
+6K251395The Rialto™ SI Fusion SystemMedtronic Sofamor Danek USA, Inc.20251—
+6K251154RIVA Posterior Fixation System; RIVA Posterior Fixation System Navigation InstrumentsHt Medical D.B.A. Xenix Medical20251—
+6K243419Altus Spine Navigation SystemAltus Partners, LLC20250—
+6K242806Medyssey Navigation SystemMedyssey Co, Ltd.20250—
+6K250182Innovasis Navigation InstrumentsInnovasis, Inc.202521
+6K250380Surgify Halo (54.085.SHD.H1); Surgify Halo (54.140.SHD.H1); Surgify Halo…Surgify Medical OY202525
+6K243073AnyPlus Navigated Instruments SystemGS Medical Co., Ltd.20240—
+6K243007CD Horizon™ Spinal SystemMedtronic Sofamor Danek USA, Inc.20243—
+6K240340Surgical Drive System (Model: ES70, ES90, E8)Guangdong Jinme Medical Technology Co., Ltd.20240—
+6K233036Ultrasonic Surgical SystemHunan Handlike Minimally Invasive Surgery Co., Ltd.20240—