Unity Knee PS-C Tibial Insert
K-Number: K240875 · 2024-06-26
ApplicantCorin U.S.A. Limited
Decision Date2024-06-26
Product CodeJWH
Advisory CommitteeOR
DecisionSubstantially Equivalent
Device Summary
Unity Knee PS-C Tibial Insert is a medical device manufactured by Corin U.S.A. Limited. It received FDA 510(k) clearance on 2024-06-26 under approval number K240875. 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 Unity Knee PS-C Tibial Insert?
Unity Knee PS-C Tibial Insert is a medical device that received FDA 510(k) clearance on 2024-06-26. It is manufactured by Corin U.S.A. Limited. The 510(k) number is K240875.
When was Unity Knee PS-C Tibial Insert approved by the FDA?
Unity Knee PS-C Tibial Insert received FDA 510(k) clearance on 2024-06-26, under approval number K240875.
What company makes Unity Knee PS-C Tibial Insert?
Unity Knee PS-C Tibial Insert is manufactured by Corin U.S.A. Limited.
What is the FDA product code for Unity Knee PS-C Tibial Insert?
The FDA product code for Unity Knee PS-C Tibial Insert 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.