MySpine Unilateral Guides— 510(k) K231483

Substantially Equivalent

Medacta International S.A.

FDA 510(k) clearance K231483 for MySpine Unilateral Guides, Substantially Equivalent on 2023-07-21. Applicant: Medacta International S.A..

Clearance details

Applicant: Medacta International S.A.
Product code: Code PQC
Advisory panel: Orthopedic
Date received: 2023-05-23
Decision date: 2023-07-21
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Castel San Pietro, CH

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