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FDA 510(k)

MSS - Monobloc stem

K-Number: K250644 · 2026-02-03

ApplicantMedacta International S.A.
Decision Date2026-02-03
Product CodePHX
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

MSS - Monobloc stem 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 2026-02-03 under 510(k) number K250644. 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 - Monobloc stem?

MSS - Monobloc stem is a medical device that received FDA 510(k) clearance on 2026-02-03. The listed applicant is Medacta International S.A.. The 510(k) number is K250644.

When did MSS - Monobloc stem receive FDA 510(k) clearance?

MSS - Monobloc stem received FDA 510(k) clearance on 2026-02-03, under 510(k) number K250644.

Who is the listed applicant for MSS - Monobloc stem?

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 MSS - Monobloc stem?

The FDA product code for MSS - Monobloc stem is PHX.

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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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