510(k) Report

Devices descending from K011444

36 later devices reach Anspach Emax Drill System through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K133604Anspach EG1 High Speed System, G1 AttachmentsThe Anspach Effort, Inc.2014111
+1K131053Anspach Xmax, EMAX2 and EMAX2 Plus System with Otologic Attachment SystemThe Anspach Effort, Inc.201313
+1K080802Emax 2 Plus System, Model Emax 2 Plus Motor, Emax 2 Console>Firmware Upgrade, Emax 2 FP…The Anspach Effort, Inc.20081435
+1K080444Conmed Linvatec Osprey Drill SystemConmed Linvatec20080—
+1K030576Anspach Irrigation Pump and Irrigation Pump IIThe Anspach Effort, Inc.200321
+1K022986The Bioplate Battery Powered DrillBioplate, Inc.20020—
+1K022942CraniocutAesculap, Inc.20020—
+1K022907Anspach Powered Kerrison System (PKS)The Anspach Effort, Inc.20021—
+1K020688Hydrocision Arthojet System with Cautery and TurboburrHydrocision, Inc.20028—
+2K220485Wireless Hand Control, EG1A (WIRELESS-HC), Receiver for Wireless Hand Control, EG1A…The Anspach Effort, Inc.20220—
+2K173066OSSEODUO Shaver and Drill SystemBien-Air Surgery SA20183—
+2K180063OCM-G1 AttachmentThe Anspach Effort, Inc.20180—
+2K113476Anspach Dissection ToolsThe Anspach Effort, Inc.20111339
+2K061108Stryker Auto Irrigation SystemStryker20070—
+2K063688Surgical Irrigation System, Irrigation TubeThe Anspach Effort, Inc.20070—
+2K062413Aesculap Pneumatic KerrisonAesculap, Inc.20060—
+2K032529Hydrocision Arthrojet System with Cautery, Turboburr and Curette, Models 51300, 51310Hydrocision, Inc.200362
+2K031406Exojet Tissue Management SystemMitek Worldwide20030—
+3K233153Traus SSG10 Surgical SystemSaeshin Precision Co., Ltd.20240—
+3K232938Traus SSG30 Surgical SystemSaeshin Precision Co., Ltd.20240—
+3K213697ORiGO SystemBien-Air Surgery SA20220—
+3K183203ELAN 4 ToolsAesculap, Inc.20190—
+3K183545Anspach Helix Dissection ToolsThe Anspach Effort, Inc.20190—
+3K182527ELAN 4 ToolsAesculap, Inc.20190—
+3K172709ELAN 4 Electro Motor System ToolsAesculap, Inc.20181—
+3K130755Hicut Highspeed InstrumentAdeor Medical AG20144—
+3K041233Arthrojet XTHydrocision, Inc.20045—
+4K232684Surgify HaloSurgify Medical OY20233—
+4K200729HydroCision SpineJet SystemHydrocision, Inc.20200—
+4K190804HydroCision TenJet DeviceHydrocision, Inc.20190—
+4K122861XTOOLOuroboros Medical20121—
+4K090303Xtend-ST Nucleus Removal System, Model 9004Corespine Technologies, LLC20090—
+5K250380Surgify Halo (54.085.SHD.H1); Surgify Halo (54.140.SHD.H1); Surgify Halo…Surgify Medical OY202525
+5K213978TELIGEN SystemMedos International SARL20220—
+6K251433Surgify Halo (54.085.SHD.H1); Surgify Halo (54.140.SHD.H1); Surgify Halo…Surgify Medical OY202513
+7K253627Surgify Halo (54.085.SHD.U1); Surgify Halo (54.140.SHD. U1); Surgify Halo…Surgify Medical OY2026011