NextAR(TM) Shoulder Platform— 510(k) K251737

Substantially Equivalent

Medacta International S.A.

FDA 510(k) clearance K251737 for NextAR(TM) Shoulder Platform, Substantially Equivalent on 2025-09-04. Applicant: Medacta International S.A..

Clearance details

Applicant: Medacta International S.A.
Product code: Code SBF
Advisory panel: Neurology
Date received: 2025-06-06
Decision date: 2025-09-04
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Castel San Pietro, CH

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