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FDA 510(k)

HOWMEDICA(R) 28MM ZIRCONIA FEMORAL HEADS

K-Number: K946026 · 1995-03-20

ApplicantHowmedica, Inc.
Decision Date1995-03-20
Product CodeLZO
Advisory CommitteeOR
DecisionSubstantially Equivalent for Some Indications

Device Summary

HOWMEDICA(R) 28MM 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 1995-03-20 under 510(k) number K946026. 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 HOWMEDICA(R) 28MM ZIRCONIA FEMORAL HEADS?

HOWMEDICA(R) 28MM ZIRCONIA FEMORAL HEADS is a medical device that received FDA 510(k) clearance on 1995-03-20. The listed applicant is Howmedica, Inc.. The 510(k) number is K946026.

When did HOWMEDICA(R) 28MM ZIRCONIA FEMORAL HEADS receive FDA 510(k) clearance?

HOWMEDICA(R) 28MM ZIRCONIA FEMORAL HEADS received FDA 510(k) clearance on 1995-03-20, under 510(k) number K946026.

Who is the listed applicant for HOWMEDICA(R) 28MM 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 HOWMEDICA(R) 28MM ZIRCONIA FEMORAL HEADS?

The FDA product code for HOWMEDICA(R) 28MM ZIRCONIA FEMORAL HEADS is LZO.

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Related Devices (Code: 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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