Velocity Alpha MR High Speed Surgical Drill System— 510(k) K253772

Substantially Equivalent

Adeor Medical AG

FDA 510(k) clearance K253772 for Velocity Alpha MR High Speed Surgical Drill System, Substantially Equivalent on 2026-03-06. Applicant: Adeor Medical AG.

Clearance details

Applicant
Adeor Medical AG
Product code
Code HBB
Advisory panel
Neurology
Date received
Decision date
Decision
Substantially Equivalent
Clearance type
Traditional
Location
Valley, DE
Download summary PDFView on FDA.gov ↗

Adverse events under product code HBB

product code HBB
Malfunction
2,656
Total
2,656

Source: openFDA MAUDE database, through . Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →

Data sourced from openFDA. This site is unofficial and independent of the FDA.