Atlas FDA

HBB

27 FDA 510(k) clearances · Product code

90 daysmedian time to decision
300 days90th percentile
27clearances measured

FDA profile

Official device name
Motor, Drill, Pneumatic
Device class
Class II (moderate risk)
Regulation
21 CFR 882.4370
Medical specialty
Neurology
Flags
Third-party review eligible
Adverse events (MAUDE)
2021: 260 · 2022: 172 · 2023: 180 · 2024: 759 · 2025: 1,040 · 2026: 912
Reports received by FDA, not confirmed device causation - volume tracks device popularity as much as risk.
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RecordFirmDate
Velocity Alpha MR High Speed Surgical Drill System (K253772)Adeor Medical AG2026-03-06
ELAN 4 Air Motor System (K172907)Aesculap, Inc.2018-11-09
Medtronic Legend Pneumatic; MR7 Pneumatic; Triton Pneumatic Drill System incorporating various Pneumatic Handpieces; Attachments; Surgical Dissecting Tools; and System Accessories (K163182)Medtronic Powered Surgical Solutions2017-03-23
Stryker Maestro Air Motors (K150801)Stryker Corporation2015-05-22
LEGEND POWER ADAPTER MODEL: 6475000 (K101168)Medtronic Sofamor Danek2010-08-24
SYNTHES AIR PEN DRIVE (APD) SYSTEM (K093361)Synthes (Usa)2010-04-14
MIDAS REX MR7 PNEUMATIC HIGH SPEED SYSTEM, MODELS PM700, PM710, PC700, PC710, PC720, PA700 (K090112)Medtronic Powered Surgical Solutions2009-03-26
ANSPACH IMRI SAFE SURGICAL DRILL SYSTEM (K061297)The Anspach Effort, Inc.2007-01-26
STRYKER ARIA PNEUMATIC SYSTEM (K061725)Stryker Instruments2006-10-26
MEDICON VIPAIR HIGH SPEED SYSTEM (K042974)Medicon EG2005-01-13
STRYKER MAESTRO SYSTEM (K041754)Stryker Corp.2004-09-07
ANSPACH MRI SAFE SURGICAL DRILL SYSTEM (K040186)The Anspach Effort, Inc.2004-04-15
DRILL GUIDE ATTACHMENT (PN 3105 DG) OF THE SODEM HIGH SPEED SYSTEM (PNEUMATIC) (K023066)Sodemsystems2002-11-25
MEDTRONIC MIDA REX LEGEND SYSTEM, MIDAS REX LEGEND PNEUMATIC HIGH SPEED SYSTEM OR LEGEND SYSTEM (K020069)Medtronic Midas Rex2002-03-18
ZMM 2000 ZEPPELIN MILLENNIUM MOTORDRILL SYSTEM (K013091)Von Zeppelin GmbH2002-01-25
CRANIAL DRILL (K000195)Image-Guided Neurologics, Inc.2000-04-20
SODEM PERFORATOR DRIVE (K993851)Sodemsystems1999-12-27
MODIFICATION TO SODEM HIGH SPEED SYSTEM FOR NEUROSURGICAL USE (K994175)Sodemsystems1999-12-21
KOMET XK-95 PERFORATOR MOTOR (MI-102) (K991625)Komet Medical1999-07-30
TRITON HUDSON CHUCK ATTACHMENT (K983092)Mednext, Inc.1998-11-06
AESCULAP HILAN MOTOR SYSTEM (K980686)Aesculap, Inc.1998-09-02
MIDAS REX MOTOR (K972289)Midas Rex Pneumatic Tools, Inc.1997-09-12
SODEM HIGH SPEED SYSTEM FOR NEUROSURGERY & MEDIAN STERNOTOMY (K954717)Sodem Diffusion SA1997-01-22
ANSPAHC SPEED REDUCER (K960630)The Anspach Effort, Inc.1996-11-19
MIDAS REX III MOTOR (K962483)Midas Rex Pneumatic Tools, Inc.1996-11-19
MIDAS REX MOTORS, (MIDAS I, MIDAS II & CONVERTIBLE MODELS) (K953434)Midas Rex Pneumatic Tools, Inc.1996-05-16
MICROMEDICS SURGICAL DRILL SYSTEM (K895739)Micromedics, Inc.1989-10-13

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