MyKnee UNI-ST
K-Number: K231037 · 2023-06-09
ApplicantMedacta International S.A.
Decision Date2023-06-09
Product CodeJWH
Advisory CommitteeOR
DecisionSubstantially Equivalent
Device Summary
MyKnee UNI-ST is a medical device manufactured by Medacta International S.A.. It received FDA 510(k) clearance on 2023-06-09 under approval number K231037. The device is classified under product code JWH. It was reviewed by the OR advisory panel. FDA Decision: Substantially Equivalent.
Frequently Asked Questions
What is the MyKnee UNI-ST?
MyKnee UNI-ST is a medical device that received FDA 510(k) clearance on 2023-06-09. It is manufactured by Medacta International S.A.. The 510(k) number is K231037.
When was MyKnee UNI-ST approved by the FDA?
MyKnee UNI-ST received FDA 510(k) clearance on 2023-06-09, under approval number K231037.
What company makes MyKnee UNI-ST?
MyKnee UNI-ST is manufactured by Medacta International S.A..
What is the FDA product code for MyKnee UNI-ST?
The FDA product code for MyKnee UNI-ST is JWH.
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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.