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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 the device name listed in this FDA 510(k) record. The listed applicant is Medacta International S.A.. It received FDA 510(k) clearance on 2025-09-04 under 510(k) 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. The listed applicant is Medacta International S.A.. The 510(k) number is K251737.

When did NextAR(TM) Shoulder Platform receive FDA 510(k) clearance?

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

Who is the listed applicant for NextAR(TM) Shoulder Platform?

The FDA 510(k) record lists Medacta International S.A. as the applicant. This does not by itself establish the device manufacturer.

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

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

Other records listing Medacta International S.A. as applicant

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Related Devices (Code: SBF)

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

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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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