FDA 510(k)

V40 ZIRCONIA FEMORAL HEADS

K-Number: K972361 · 1997-09-23

Decision Date1997-09-23

Product CodeLZO

Advisory CommitteeOR

DecisionSubstantially Equivalent for Some Indications

Device Summary

V40 ZIRCONIA FEMORAL HEADS is the device name listed in this FDA 510(k) record. The listed applicant is Howmedica, Inc.. It received FDA 510(k) clearance on 1997-09-23 under 510(k) number K972361. The device is classified under product code LZO. It was reviewed by the OR advisory panel. FDA Decision: Substantially Equivalent for Some Indications.

Frequently Asked Questions

What is the V40 ZIRCONIA FEMORAL HEADS?

V40 ZIRCONIA FEMORAL HEADS is a medical device that received FDA 510(k) clearance on 1997-09-23. The listed applicant is Howmedica, Inc.. The 510(k) number is K972361.

When did V40 ZIRCONIA FEMORAL HEADS receive FDA 510(k) clearance?

V40 ZIRCONIA FEMORAL HEADS received FDA 510(k) clearance on 1997-09-23, under 510(k) number K972361.

Who is the listed applicant for V40 ZIRCONIA FEMORAL HEADS?

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

What is the FDA product code for V40 ZIRCONIA FEMORAL HEADS?

The FDA product code for V40 ZIRCONIA 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.