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FDA 510(k)

ACUMATCH C-SERIES CEMENTED FEMORAL COMPONENT, MODEL SIZE 0

K-Number: K012493 · 2001-08-29

ApplicantExactech, Inc.
Decision Date2001-08-29
Product CodeJDI
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

ACUMATCH C-SERIES CEMENTED FEMORAL COMPONENT, MODEL SIZE 0 is the device name listed in this FDA 510(k) record. The listed applicant is Exactech, Inc.. It received FDA 510(k) clearance on 2001-08-29 under 510(k) number K012493. The device is classified under product code JDI. It was reviewed by the OR advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the ACUMATCH C-SERIES CEMENTED FEMORAL COMPONENT, MODEL SIZE 0?

ACUMATCH C-SERIES CEMENTED FEMORAL COMPONENT, MODEL SIZE 0 is a medical device that received FDA 510(k) clearance on 2001-08-29. The listed applicant is Exactech, Inc.. The 510(k) number is K012493.

When did ACUMATCH C-SERIES CEMENTED FEMORAL COMPONENT, MODEL SIZE 0 receive FDA 510(k) clearance?

ACUMATCH C-SERIES CEMENTED FEMORAL COMPONENT, MODEL SIZE 0 received FDA 510(k) clearance on 2001-08-29, under 510(k) number K012493.

Who is the listed applicant for ACUMATCH C-SERIES CEMENTED FEMORAL COMPONENT, MODEL SIZE 0?

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 C-SERIES CEMENTED FEMORAL COMPONENT, MODEL SIZE 0?

The FDA product code for ACUMATCH C-SERIES CEMENTED FEMORAL COMPONENT, MODEL SIZE 0 is JDI.

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Related Devices (Code: JDI)

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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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