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FDA 510(k)

EXACTECH CERAMIC FEMORAL HEAD COMPONENT

K-Number: K914574 · 1992-01-13

ApplicantExactech, Inc.
Decision Date1992-01-13
Product CodeLZO
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

EXACTECH CERAMIC 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 1992-01-13 under 510(k) number K914574. 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 CERAMIC FEMORAL HEAD COMPONENT?

EXACTECH CERAMIC FEMORAL HEAD COMPONENT is a medical device that received FDA 510(k) clearance on 1992-01-13. The listed applicant is Exactech, Inc.. The 510(k) number is K914574.

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

EXACTECH CERAMIC FEMORAL HEAD COMPONENT received FDA 510(k) clearance on 1992-01-13, under 510(k) number K914574.

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

The FDA product code for EXACTECH CERAMIC FEMORAL HEAD COMPONENT 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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