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FDA 510(k)

EXACTECH ZIRAMIC FEMORAL HEAD COMPONENT

K-Number: K931617 · 1994-06-14

ApplicantExactech, Inc.
Decision Date1994-06-14
Product CodeLZO
Advisory CommitteeOR
DecisionSubstantially Equivalent for Some Indications

Device Summary

EXACTECH ZIRAMIC FEMORAL HEAD COMPONENT is the device name listed in this FDA 510(k) record. The listed applicant is Exactech, Inc.. It received FDA 510(k) clearance on 1994-06-14 under 510(k) number K931617. 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 EXACTECH ZIRAMIC FEMORAL HEAD COMPONENT?

EXACTECH ZIRAMIC FEMORAL HEAD COMPONENT is a medical device that received FDA 510(k) clearance on 1994-06-14. The listed applicant is Exactech, Inc.. The 510(k) number is K931617.

When did EXACTECH ZIRAMIC FEMORAL HEAD COMPONENT receive FDA 510(k) clearance?

EXACTECH ZIRAMIC FEMORAL HEAD COMPONENT received FDA 510(k) clearance on 1994-06-14, under 510(k) number K931617.

Who is the listed applicant for EXACTECH ZIRAMIC FEMORAL HEAD COMPONENT?

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 FEMORAL HEAD COMPONENT?

The FDA product code for EXACTECH ZIRAMIC FEMORAL HEAD COMPONENT 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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