Actis DuoFix Hip Prosthesis- Collarless
K-Number: K210581 · 2021-05-20
ApplicantDepuy Ireland UC
Decision Date2021-05-20
Product CodeMEH
Advisory CommitteeOR
DecisionSubstantially Equivalent
Device Summary
Actis DuoFix Hip Prosthesis- Collarless is a medical device manufactured by Depuy Ireland UC. It received FDA 510(k) clearance on 2021-05-20 under approval number K210581. 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 Actis DuoFix Hip Prosthesis- Collarless?
Actis DuoFix Hip Prosthesis- Collarless is a medical device that received FDA 510(k) clearance on 2021-05-20. It is manufactured by Depuy Ireland UC. The 510(k) number is K210581.
When was Actis DuoFix Hip Prosthesis- Collarless approved by the FDA?
Actis DuoFix Hip Prosthesis- Collarless received FDA 510(k) clearance on 2021-05-20, under approval number K210581.
What company makes Actis DuoFix Hip Prosthesis- Collarless?
Actis DuoFix Hip Prosthesis- Collarless is manufactured by Depuy Ireland UC.
What is the FDA product code for Actis DuoFix Hip Prosthesis- Collarless?
The FDA product code for Actis DuoFix Hip Prosthesis- Collarless 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.