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FDA 510(k)

EXACTECH TOTAL HIP SYSTME: 22MM FEMORAL HEAD

K-Number: K964262 · 1996-12-27

ApplicantExactech, Inc.
Decision Date1996-12-27
Product CodeJDI
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

EXACTECH TOTAL HIP SYSTME: 22MM FEMORAL HEAD is the device name listed in this FDA 510(k) record. The listed applicant is Exactech, Inc.. It received FDA 510(k) clearance on 1996-12-27 under 510(k) number K964262. 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 EXACTECH TOTAL HIP SYSTME: 22MM FEMORAL HEAD?

EXACTECH TOTAL HIP SYSTME: 22MM FEMORAL HEAD is a medical device that received FDA 510(k) clearance on 1996-12-27. The listed applicant is Exactech, Inc.. The 510(k) number is K964262.

When did EXACTECH TOTAL HIP SYSTME: 22MM FEMORAL HEAD receive FDA 510(k) clearance?

EXACTECH TOTAL HIP SYSTME: 22MM FEMORAL HEAD received FDA 510(k) clearance on 1996-12-27, under 510(k) number K964262.

Who is the listed applicant for EXACTECH TOTAL HIP SYSTME: 22MM FEMORAL HEAD?

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 TOTAL HIP SYSTME: 22MM FEMORAL HEAD?

The FDA product code for EXACTECH TOTAL HIP SYSTME: 22MM FEMORAL HEAD 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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