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FDA 510(k)

NextAR(TM) Shoulder Platform

K-Number: K251737 · 2025-09-04

ApplicantMedacta International S.A.
Decision Date2025-09-04
Product CodeSBF
Advisory CommitteeNE
DecisionSubstantially Equivalent

Device Summary

NextAR(TM) Shoulder Platform is a medical device manufactured by Medacta International S.A.. It received FDA 510(k) clearance on 2025-09-04 under approval number K251737. The device is classified under product code SBF. It was reviewed by the NE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the NextAR(TM) Shoulder Platform?

NextAR(TM) Shoulder Platform is a medical device that received FDA 510(k) clearance on 2025-09-04. It is manufactured by Medacta International S.A.. The 510(k) number is K251737.

When was NextAR(TM) Shoulder Platform approved by the FDA?

NextAR(TM) Shoulder Platform received FDA 510(k) clearance on 2025-09-04, under approval number K251737.

What company makes NextAR(TM) Shoulder Platform?

NextAR(TM) Shoulder Platform is manufactured by Medacta International S.A..

What is the FDA product code for NextAR(TM) Shoulder Platform?

The FDA product code for NextAR(TM) Shoulder Platform is SBF.

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Official Source

View on FDA Database →

Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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