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FDA 510(k)

EXACTECH ALL POLY ACETABULAR CUP

K-Number: K963313 · 1996-11-14

ApplicantExactech, Inc.
Decision Date1996-11-14
Product CodeJDI
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

EXACTECH ALL POLY ACETABULAR CUP is the device name listed in this FDA 510(k) record. The listed applicant is Exactech, Inc.. It received FDA 510(k) clearance on 1996-11-14 under 510(k) number K963313. 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 ALL POLY ACETABULAR CUP?

EXACTECH ALL POLY ACETABULAR CUP is a medical device that received FDA 510(k) clearance on 1996-11-14. The listed applicant is Exactech, Inc.. The 510(k) number is K963313.

When did EXACTECH ALL POLY ACETABULAR CUP receive FDA 510(k) clearance?

EXACTECH ALL POLY ACETABULAR CUP received FDA 510(k) clearance on 1996-11-14, under 510(k) number K963313.

Who is the listed applicant for EXACTECH ALL POLY ACETABULAR CUP?

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 ALL POLY ACETABULAR CUP?

The FDA product code for EXACTECH ALL POLY ACETABULAR CUP 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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