FDA 510(k)

22.2mm BIOLOX® delta Ceramic V40™ Femoral Heads

Numéro K : K234025 · 2024-04-24

DemandeurHowmedica Osteonics Corp., Dba Stryker Orthopaedics

Date de décision2024-04-24

Code produitLZO

Comité consultatifOR

DécisionSubstantially Equivalent

Résumé du dispositif

22.2mm BIOLOX® delta Ceramic V40™ Femoral Heads 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 2024-04-24 under 510(k) number K234025. The device is classified under product code LZO. It was reviewed by the OR advisory panel. FDA Decision: Substantially Equivalent.

Questions fréquentes

What is the 22.2mm BIOLOX® delta Ceramic V40™ Femoral Heads?

22.2mm BIOLOX® delta Ceramic V40™ Femoral Heads is a medical device that received FDA 510(k) clearance on 2024-04-24. The listed applicant is Howmedica Osteonics Corp., Dba Stryker Orthopaedics. The 510(k) number is K234025.

When did 22.2mm BIOLOX® delta Ceramic V40™ Femoral Heads receive FDA 510(k) clearance?

22.2mm BIOLOX® delta Ceramic V40™ Femoral Heads received FDA 510(k) clearance on 2024-04-24, under 510(k) number K234025.

Who is the listed applicant for 22.2mm BIOLOX® delta Ceramic V40™ Femoral Heads?

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 22.2mm BIOLOX® delta Ceramic V40™ Femoral Heads?

The FDA product code for 22.2mm BIOLOX® delta Ceramic V40™ Femoral Heads is LZO.

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Source officielle

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