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 a medical device manufactured by Medacta International S.A.. It received FDA 510(k) clearance on 2025-06-13 under approval 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. It is manufactured by Medacta International S.A.. The 510(k) number is K251166.
When was Mfinity Femoral System approved by the FDA?
Mfinity Femoral System received FDA 510(k) clearance on 2025-06-13, under approval number K251166.
What company makes Mfinity Femoral System?
Mfinity Femoral System is manufactured by Medacta International S.A..
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.