FDA 510(k) clearance · back to tracker

Velocity Alpha MR High Speed Surgical Drill System

Adeor Medical AG cleared K253772 on 2026-03-06, decision: substantially equivalent

K-number

K253772

Sponsor

Adeor Medical AG

Device

Velocity Alpha MR High Speed Surgical Drill System

Class

Class II

Decision

Substantially Equivalent

Decision date

2026-03-06

Product code

HBB

Advisory committee

Neurology

Medical specialty

Neurology

Regulation number

882.4370

Official FDA record

Open K253772on accessdata.fda.gov →

FDA's authoritative 510(k) summary page. Includes the decision letter, predicate references, and downloadable substantial-equivalence determination.

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Source

Public 510(k) database, U.S. Food and Drug Administration, accessed via openFDA. Page refreshed weekly.