Atlas FDA

HBC

26 FDA 510(k) clearances · Product code

91 daysmedian time to decision
359 days90th percentile
26clearances measured

FDA profile

Official device name
Motor, Drill, Electric
Device class
Class II (moderate risk)
Regulation
21 CFR 882.4360
Medical specialty
Neurology
Flags
Third-party review eligible
Adverse events (MAUDE)
2021: 946 · 2022: 760 · 2023: 663 · 2024: 427 · 2025: 648 · 2026: 64
Reports received by FDA, not confirmed device causation - volume tracks device popularity as much as risk.
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Export predicate table (CSV) Shareable report ◉ Watch exports: 3 free/month · reports & watching: free

RecordFirmDate
Traus SSG10 Surgical System (K233153)Saeshin Precision Co., Ltd.2024-09-20
Traus SSG30 Surgical System (K232938)Saeshin Precision Co., Ltd.2024-09-16
ORiGO System (K213697)Bien-Air Surgery SA2022-10-31
Wireless Hand Control, EG1A (WIRELESS-HC), Receiver for Wireless Hand Control, EG1A (RECEIVER-HC) (K220485)The Anspach Effort, Inc.2022-05-19
hekaDrill (K193630)Zethon, Ltd.2021-04-09
MR8 Drill System, Midas Rex MR8 ClearView Tools (K183515)Medtronic Powered Surgical Solutions2019-05-12
OSSEODUO Shaver and Drill System (K173066)Bien-Air Surgery SA2018-06-22
IPC systems, Legend EHS handpieces and Legend Stylus Touch handpiece, Microsaw handpieces,Triton electric high torque handpiece, Attachments and surgical dissecting tools (K170312)Medtronic Powered Surgical Solutions2017-05-15
MR8 Drill System (K163565)Medtronic Powered Surgical Solutions2017-03-28
ELAN 4 Motor System (K152960)Aesculap, Inc.2016-07-22
ANSPACH EG1 HIGH SPEED SYSTEM, G1 ATTACHMENTS (K133604)The Anspach Effort, Inc.2014-01-10
PRIMADO2 TOTAL SURGICAL SYSTEM (K132264)Nakanishi, Inc.2013-12-17
D4000 DRIVE SYSTEM; D4000A DRIVE SYSTEM WITH IRRIGATION (K130497)Linvatec Corporation D/B/A Conmed Linvatec2013-03-29
PRIMADO (K083112)Nakanishi, Inc.2009-04-29
CONMED LINVATEC OSPREY DRILL SYSTEM (K080444)Conmed Linvatec2008-04-02
MICROPOWER HAND PIECE HIGH SPEED DRILL (K060260)Linvatec Corp.2006-04-10
MICROSPEED UNI MOTOR SYSTEM (K053526)Aesculap, Inc.2006-01-18
THE BIOPLATE BATTERY POWERED DRILL (K022986)Bioplate, Inc.2002-11-19
SODEM HIGH SPEED SYSTEM (ELECTRIC) (NEURO/SPINE SURGERY) (K012457)Sodemsystems2001-10-22
SODEM HIGH SPEED SYSTEM (ELECTRIC) (GENERAL ORTHOPEDICS & PLASTIC SURGERY) (K012453)Sodemsystems2001-10-22
ANSPACH EMAX DRILL SYSTEM (K011444)The Anspach Effort, Inc.2001-08-08
MICROSPEED EC MOTORSYSTEM GD650/GD653 (K003612)Aesculap, Inc.2001-02-20
ADVANTAGE DRIVE SYSTEM (K002523)Linvatec Corp.2000-10-06
SERVOTRONIC EC100 SYSTEM (K972857)Medicon EG1998-01-16
SURGICAL DRILL (ELECTRIC) INCLUDING HANDPIECE (K862989)Entronics1986-08-21
450/800 DRILL (K812436)Black & Decker(Tm)1981-11-02

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Every clearance here is in the API, with alerts when new ones post.