ANKYRAS— 510(k) K250160

Substantially Equivalent

Mentice Spain S.L.

FDA 510(k) clearance K250160 for ANKYRAS, Substantially Equivalent on 2025-05-06. Applicant: Mentice Spain S.L.. Device class: 2.

Clearance details

Applicant
Mentice Spain S.L.
Product code
Code PZO
Device class
Class 2
Regulation
21 CFR 892.2050
Advisory panel
Radiology
Date received
Decision date
Decision
Substantially Equivalent
Clearance type
Traditional
Location
Barcelona, ES
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