510(k) Report

Devices descending from K003612

15 later devices reach Microspeed EC Motorsystem GD650/GD653 through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K053526Microspeed Uni Motor SystemAesculap, Inc.2006121
+1K022986The Bioplate Battery Powered DrillBioplate, Inc.20020—
+1K022942CraniocutAesculap, Inc.20020—
+2K152960ELAN 4 Motor SystemAesculap, Inc.20163—
+2K132264PRIMADO2 Total Surgical SystemNakanishi, Inc.20136—
+2K080444Conmed Linvatec Osprey Drill SystemConmed Linvatec20080—
+3K233638VERZA™ High Speed DrillsGlobus Medical, Inc.20241—
+3K213221AMADEO, M-UK1015 (incl. attachments and accessories)W&H Dentalwerk Buermoss GmbH20221—
+3K202120P300 AttachmentNakanishi, Inc.20211—
+3K203739ELAN 4 Electro Motor SystemAesculap, Inc.20210—
+3K191479Velocity Alpha Highspeed Surgical Drill SystemAdeor Medical AG20210—
+3K172907ELAN 4 Air Motor SystemAesculap, Inc.201802
+4K252662UniBurNakanishi, Inc.20250—
+4K240340Surgical Drive System (Model: ES70, ES90, E8)Guangdong Jinme Medical Technology Co., Ltd.20240—
+4K240568DuraPro™ Oscillating SystemGlobus Medical, Inc.20240—