NextAR(TM) Spine— 510(k) K250477

Substantially Equivalent

Medacta International S.A.

FDA 510(k) clearance K250477 for NextAR(TM) Spine, Substantially Equivalent on 2025-07-31. Applicant: Medacta International S.A.. Device class: 2.

Clearance details

Applicant: Medacta International S.A.
Product code: Code SBF
Device class: Class 2
Regulation: 21 CFR 882.4560
Advisory panel: Neurology
Date received: 2025-02-19
Decision date: 2025-07-31
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Castel San Pietro, CH

Download summary PDF View on FDA.gov ↗

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