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FDA 510(k)

22.2mm BIOLOX® delta Ceramic V40™ Femoral Heads

K-Number: K234025 · 2024-04-24

Decision Date2024-04-24
Product CodeLZO
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

22.2mm BIOLOX® delta Ceramic V40™ Femoral Heads is a medical device manufactured by Howmedica Osteonics Corp., Dba Stryker Orthopaedics. It received FDA 510(k) clearance on 2024-04-24 under approval number K234025. The device is classified under product code LZO. It was reviewed by the OR advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

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. It is manufactured by Howmedica Osteonics Corp., Dba Stryker Orthopaedics. The 510(k) number is K234025.

When was 22.2mm BIOLOX® delta Ceramic V40™ Femoral Heads approved by the FDA?

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

What company makes 22.2mm BIOLOX® delta Ceramic V40™ Femoral Heads?

22.2mm BIOLOX® delta Ceramic V40™ Femoral Heads is manufactured by Howmedica Osteonics Corp., Dba Stryker Orthopaedics.

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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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.