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FDA 510(k)

EXACTECH ACUMATCH A-SERIES AND MCS ACETABULAR SHELLS AND LINERS

K-Number: K040613 · 2004-06-04

ApplicantExactech, Inc.
Decision Date2004-06-04
Product CodeMEH
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

EXACTECH ACUMATCH A-SERIES AND MCS ACETABULAR SHELLS AND LINERS is the device name listed in this FDA 510(k) record. The listed applicant is Exactech, Inc.. It received FDA 510(k) clearance on 2004-06-04 under 510(k) number K040613. The device is classified under product code MEH. It was reviewed by the OR advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the EXACTECH ACUMATCH A-SERIES AND MCS ACETABULAR SHELLS AND LINERS?

EXACTECH ACUMATCH A-SERIES AND MCS ACETABULAR SHELLS AND LINERS is a medical device that received FDA 510(k) clearance on 2004-06-04. The listed applicant is Exactech, Inc.. The 510(k) number is K040613.

When did EXACTECH ACUMATCH A-SERIES AND MCS ACETABULAR SHELLS AND LINERS receive FDA 510(k) clearance?

EXACTECH ACUMATCH A-SERIES AND MCS ACETABULAR SHELLS AND LINERS received FDA 510(k) clearance on 2004-06-04, under 510(k) number K040613.

Who is the listed applicant for EXACTECH ACUMATCH A-SERIES AND MCS ACETABULAR SHELLS AND LINERS?

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 ACUMATCH A-SERIES AND MCS ACETABULAR SHELLS AND LINERS?

The FDA product code for EXACTECH ACUMATCH A-SERIES AND MCS ACETABULAR SHELLS AND LINERS is MEH.

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Related Devices (Code: MEH)

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

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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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