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FDA 510(k)

MSS - Humeral reverse liners extension

K-Number: K261016 · 2026-06-10

ApplicantMedacta International, SA
Decision Date2026-06-10
Product CodePHX
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

MSS - Humeral reverse liners extension is the device name listed in this FDA 510(k) record. The listed applicant is Medacta International, SA. It received FDA 510(k) clearance on 2026-06-10 under 510(k) number K261016. The device is classified under product code PHX. It was reviewed by the OR advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the MSS - Humeral reverse liners extension?

MSS - Humeral reverse liners extension is a medical device that received FDA 510(k) clearance on 2026-06-10. The listed applicant is Medacta International, SA. The 510(k) number is K261016.

When did MSS - Humeral reverse liners extension receive FDA 510(k) clearance?

MSS - Humeral reverse liners extension received FDA 510(k) clearance on 2026-06-10, under 510(k) number K261016.

Who is the listed applicant for MSS - Humeral reverse liners extension?

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

What is the FDA product code for MSS - Humeral reverse liners extension?

The FDA product code for MSS - Humeral reverse liners extension is PHX.

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Other records listing Medacta International, SA as applicant

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Related Devices (Code: PHX)

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

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

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