510(k) Report

Devices descending from K080802

14 later devices reach Emax 2 Plus System, Model Emax 2 Plus Motor, Emax 2 Console>Firmware Upgrade… through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K173066OSSEODUO Shaver and Drill SystemBien-Air Surgery SA20183—
+1K113476Anspach Dissection ToolsThe Anspach Effort, Inc.20111339
+2K233153Traus SSG10 Surgical SystemSaeshin Precision Co., Ltd.20240—
+2K232938Traus SSG30 Surgical SystemSaeshin Precision Co., Ltd.20240—
+2K213697ORiGO SystemBien-Air Surgery SA20220—
+2K183203ELAN 4 ToolsAesculap, Inc.20190—
+2K183545Anspach Helix Dissection ToolsThe Anspach Effort, Inc.20190—
+2K182527ELAN 4 ToolsAesculap, Inc.20190—
+2K172709ELAN 4 Electro Motor System ToolsAesculap, Inc.20181—
+2K130755Hicut Highspeed InstrumentAdeor Medical AG20144—
+3K232684Surgify HaloSurgify Medical OY20233—
+4K250380Surgify Halo (54.085.SHD.H1); Surgify Halo (54.140.SHD.H1); Surgify Halo…Surgify Medical OY202525
+5K251433Surgify Halo (54.085.SHD.H1); Surgify Halo (54.140.SHD.H1); Surgify Halo…Surgify Medical OY202513
+6K253627Surgify Halo (54.085.SHD.U1); Surgify Halo (54.140.SHD. U1); Surgify Halo…Surgify Medical OY2026011