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FDA 510(k)

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 the device name listed in this FDA 510(k) record. The listed applicant is Depuy Ireland UC. It received FDA 510(k) clearance on 2021-05-20 under 510(k) 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. The listed applicant is Depuy Ireland UC. The 510(k) number is K210581.

When did Actis DuoFix Hip Prosthesis- Collarless receive FDA 510(k) clearance?

Actis DuoFix Hip Prosthesis- Collarless received FDA 510(k) clearance on 2021-05-20, under 510(k) number K210581.

Who is the listed applicant for Actis DuoFix Hip Prosthesis- Collarless?

The FDA 510(k) record lists Depuy Ireland UC as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Actis DuoFix Hip Prosthesis- Collarless?

The FDA product code for Actis DuoFix Hip Prosthesis- Collarless is MEH.

Other records listing Depuy Ireland UC as applicant

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Related Devices (Code: MEH)

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K261576Icona Hip StemCorin, Ltd.K250375Allure Hip Stem and Intramedullary PlugsWaldemar Link GmbH & Co. KGK251166Mfinity Femoral SystemMedacta International S.A.K251052Trivicta® Hip StemOrtho Development Corp.K242315Resolve Modular Revision Hip StemUnited Orthopedic CorporationK243839Alteon® HA Femoral StemsExactech, Inc.

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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