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FDA 510(k)

EXACTECH ZIRAMIC ZIRCONIA 12/14 FEMORAL HEADS

K-Number: K050398 · 2005-11-18

ApplicantExactech, Inc.
Decision Date2005-11-18
Product CodeLZO
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

EXACTECH ZIRAMIC ZIRCONIA 12/14 FEMORAL HEADS is the device name listed in this FDA 510(k) record. The listed applicant is Exactech, Inc.. It received FDA 510(k) clearance on 2005-11-18 under 510(k) number K050398. 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 EXACTECH ZIRAMIC ZIRCONIA 12/14 FEMORAL HEADS?

EXACTECH ZIRAMIC ZIRCONIA 12/14 FEMORAL HEADS is a medical device that received FDA 510(k) clearance on 2005-11-18. The listed applicant is Exactech, Inc.. The 510(k) number is K050398.

When did EXACTECH ZIRAMIC ZIRCONIA 12/14 FEMORAL HEADS receive FDA 510(k) clearance?

EXACTECH ZIRAMIC ZIRCONIA 12/14 FEMORAL HEADS received FDA 510(k) clearance on 2005-11-18, under 510(k) number K050398.

Who is the listed applicant for EXACTECH ZIRAMIC ZIRCONIA 12/14 FEMORAL HEADS?

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

What is the FDA product code for EXACTECH ZIRAMIC ZIRCONIA 12/14 FEMORAL HEADS?

The FDA product code for EXACTECH ZIRAMIC ZIRCONIA 12/14 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.

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