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FDA 510(k)

ACUMATCH 12/14 PRESS-FIT FEMORAL STEMS

K-Number: K051335 · 2005-06-21

ApplicantExactech, Inc.
Decision Date2005-06-21
Product CodeJDI
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

ACUMATCH 12/14 PRESS-FIT FEMORAL STEMS is the device name listed in this FDA 510(k) record. The listed applicant is Exactech, Inc.. It received FDA 510(k) clearance on 2005-06-21 under 510(k) number K051335. 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 12/14 PRESS-FIT FEMORAL STEMS?

ACUMATCH 12/14 PRESS-FIT FEMORAL STEMS is a medical device that received FDA 510(k) clearance on 2005-06-21. The listed applicant is Exactech, Inc.. The 510(k) number is K051335.

When did ACUMATCH 12/14 PRESS-FIT FEMORAL STEMS receive FDA 510(k) clearance?

ACUMATCH 12/14 PRESS-FIT FEMORAL STEMS received FDA 510(k) clearance on 2005-06-21, under 510(k) number K051335.

Who is the listed applicant for ACUMATCH 12/14 PRESS-FIT FEMORAL STEMS?

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 12/14 PRESS-FIT FEMORAL STEMS?

The FDA product code for ACUMATCH 12/14 PRESS-FIT FEMORAL STEMS is JDI.

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Related Devices (Code: JDI)

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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