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FDA 510(k)

Mfinity Femoral System

K-Number: K251166 · 2025-06-13

ApplicantMedacta International S.A.
Decision Date2025-06-13
Product CodeMEH
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

Mfinity Femoral System 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 2025-06-13 under 510(k) number K251166. The device is classified under product code MEH. It was reviewed by the OR advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Mfinity Femoral System?

Mfinity Femoral System is a medical device that received FDA 510(k) clearance on 2025-06-13. The listed applicant is Medacta International S.A.. The 510(k) number is K251166.

When did Mfinity Femoral System receive FDA 510(k) clearance?

Mfinity Femoral System received FDA 510(k) clearance on 2025-06-13, under 510(k) number K251166.

Who is the listed applicant for Mfinity Femoral System?

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 Mfinity Femoral System?

The FDA product code for Mfinity Femoral System is MEH.

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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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