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FDA 510(k)

ACUMATCH L-SERIES UNIPOLAR ENDOPROSTHESIS

K-Number: K010081 · 2001-02-05

ApplicantExactech, Inc.
Decision Date2001-02-05
Product CodeKWY
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

ACUMATCH L-SERIES UNIPOLAR ENDOPROSTHESIS is the device name listed in this FDA 510(k) record. The listed applicant is Exactech, Inc.. It received FDA 510(k) clearance on 2001-02-05 under 510(k) number K010081. The device is classified under product code KWY. It was reviewed by the OR advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the ACUMATCH L-SERIES UNIPOLAR ENDOPROSTHESIS?

ACUMATCH L-SERIES UNIPOLAR ENDOPROSTHESIS is a medical device that received FDA 510(k) clearance on 2001-02-05. The listed applicant is Exactech, Inc.. The 510(k) number is K010081.

When did ACUMATCH L-SERIES UNIPOLAR ENDOPROSTHESIS receive FDA 510(k) clearance?

ACUMATCH L-SERIES UNIPOLAR ENDOPROSTHESIS received FDA 510(k) clearance on 2001-02-05, under 510(k) number K010081.

Who is the listed applicant for ACUMATCH L-SERIES UNIPOLAR ENDOPROSTHESIS?

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 ACUMATCH L-SERIES UNIPOLAR ENDOPROSTHESIS?

The FDA product code for ACUMATCH L-SERIES UNIPOLAR ENDOPROSTHESIS is KWY.

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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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