FDA.reportPublic FDA data

510(k) K253772

Device
Velocity Alpha MR High Speed Surgical Drill System
Applicant
Adeor Medical AG
510(k) number
K253772
Product code
HBB
Decision
Substantially Equivalent (SESE)
Decision date
2026-03-06
Date received
2025-11-26
Regulation
882.4370
Classification name
Motor, Drill, Pneumatic
Medical specialty
Neurology
Review panel
Neurology
Device class
2
Clearance type
Traditional
Statement or summary
Summary
Third party reviewed
N

Applicant Contact#

Contact
Silvia Laube
Address
Martinshof 5 Valley DE 83626 83626

FDA Registration Numbers#

Source Documents#

510(k) summary PDF

Other 510(k) Records For Product Code HBB#

510(k), Device, Applicant table
510(k)DeviceApplicantDecision date
K172907ELAN 4 Air Motor SystemAesculap, Inc.2018-11-09
K163182Medtronic Legend Pneumatic; MR7 Pneumatic; Triton Pneumatic Drill System incorporating various Pneumatic Handpieces; Attachments; Surgical Dissecting Tools; and System AccessoriesMedtronic Powered Surgical Solutions2017-03-23
K150801Stryker Maestro Air MotorsStryker Corporation2015-05-22
K101168LEGEND POWER ADAPTER MODEL: 6475000Medtronic Sofamor Danek2010-08-24
K093361SYNTHES AIR PEN DRIVE (APD) SYSTEMSynthes (Usa)2010-04-14
K090112MIDAS REX MR7 PNEUMATIC HIGH SPEED SYSTEM, MODELS PM700, PM710, PC700, PC710, PC720, PA700Medtronic Powered Surgical Solutions2009-03-26
K061297ANSPACH IMRI SAFE SURGICAL DRILL SYSTEMThe Anspach Effort, Inc.2007-01-26
K061725STRYKER ARIA PNEUMATIC SYSTEMStryker Instruments2006-10-26
K042974MEDICON VIPAIR HIGH SPEED SYSTEMMedicon EG2005-01-13
K041754STRYKER MAESTRO SYSTEMStryker Corp.2004-09-07
K040186ANSPACH MRI SAFE SURGICAL DRILL SYSTEMThe Anspach Effort, Inc.2004-04-15
K023066DRILL GUIDE ATTACHMENT (PN 3105 DG) OF THE SODEM HIGH SPEED SYSTEM (PNEUMATIC)Sodemsystems2002-11-25
K020069MEDTRONIC MIDA REX LEGEND SYSTEM, MIDAS REX LEGEND PNEUMATIC HIGH SPEED SYSTEM OR LEGEND SYSTEMMedtronic Midas Rex2002-03-18
K013091ZMM 2000 ZEPPELIN MILLENNIUM MOTORDRILL SYSTEMVon Zeppelin GmbH2002-01-25
K000195CRANIAL DRILLImage-Guided Neurologics, Inc.2000-04-20