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FDA 510(k)

22.2mm BIOLOX® delta Ceramic V40™ Femoral Heads

K-Number: K234025 · 2024-04-24

ApplicantHowmedica Osteonics Corp., Dba Stryker Orthopaedics
Decision Date2024-04-24
Product CodeLZO
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

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.

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. 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.

Other records listing Howmedica Osteonics Corp., Dba Stryker Orthopaedics as applicant

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Related Devices (Code: LZO)

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.

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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.

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