FDA 510(k)

Avon Patello-femoral Joint Prosthesis

Numéro K : K211303 · 2021-06-04

DemandeurHowmedica Osteonics Corp., Dba Stryker Orthopaedics

Date de décision2021-06-04

Code produitKRR

Comité consultatifOR

DécisionSubstantially Equivalent

Résumé du dispositif

Avon Patello-femoral Joint Prosthesis is the device name listed in this FDA 510(k) record. The listed applicant is Howmedica Osteonics Corp., Dba Stryker Orthopaedics. It received FDA 510(k) clearance on 2021-06-04 under 510(k) number K211303. The device is classified under product code KRR. It was reviewed by the OR advisory panel. FDA Decision: Substantially Equivalent.

Questions fréquentes

What is the Avon Patello-femoral Joint Prosthesis?

Avon Patello-femoral Joint Prosthesis is a medical device that received FDA 510(k) clearance on 2021-06-04. The listed applicant is Howmedica Osteonics Corp., Dba Stryker Orthopaedics. The 510(k) number is K211303.

When did Avon Patello-femoral Joint Prosthesis receive FDA 510(k) clearance?

Avon Patello-femoral Joint Prosthesis received FDA 510(k) clearance on 2021-06-04, under 510(k) number K211303.

Who is the listed applicant for Avon Patello-femoral Joint Prosthesis?

The FDA 510(k) record lists Howmedica Osteonics Corp., Dba Stryker Orthopaedics as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Avon Patello-femoral Joint Prosthesis?

The FDA product code for Avon Patello-femoral Joint Prosthesis is KRR.

Essais cliniques associés

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Dispositifs connexes (Code : KRR)

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Source officielle

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