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FDA 510(k)

ZIRCONIA CERAMIC FEMORAL HEAD

K-Number: K944689 · 1995-10-20

ApplicantWrightmedicaltechnologyinc
Decision Date1995-10-20
Product CodeLZO
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

ZIRCONIA CERAMIC FEMORAL HEAD is the device name listed in this FDA 510(k) record. The listed applicant is Wrightmedicaltechnologyinc. It received FDA 510(k) clearance on 1995-10-20 under 510(k) number K944689. 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 ZIRCONIA CERAMIC FEMORAL HEAD?

ZIRCONIA CERAMIC FEMORAL HEAD is a medical device that received FDA 510(k) clearance on 1995-10-20. The listed applicant is Wrightmedicaltechnologyinc. The 510(k) number is K944689.

When did ZIRCONIA CERAMIC FEMORAL HEAD receive FDA 510(k) clearance?

ZIRCONIA CERAMIC FEMORAL HEAD received FDA 510(k) clearance on 1995-10-20, under 510(k) number K944689.

Who is the listed applicant for ZIRCONIA CERAMIC FEMORAL HEAD?

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

What is the FDA product code for ZIRCONIA CERAMIC FEMORAL HEAD?

The FDA product code for ZIRCONIA CERAMIC FEMORAL HEAD 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.

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