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FDA 510(k)

EXACTECH BIPOLAR HIP PROSTHESIS

K-Number: K905370 · 1991-02-27

ApplicantExactech, Inc.
Decision Date1991-02-27
Product CodeKWY
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

EXACTECH BIPOLAR HIP PROSTHESIS is the device name listed in this FDA 510(k) record. The listed applicant is Exactech, Inc.. It received FDA 510(k) clearance on 1991-02-27 under 510(k) number K905370. 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 EXACTECH BIPOLAR HIP PROSTHESIS?

EXACTECH BIPOLAR HIP PROSTHESIS is a medical device that received FDA 510(k) clearance on 1991-02-27. The listed applicant is Exactech, Inc.. The 510(k) number is K905370.

When did EXACTECH BIPOLAR HIP PROSTHESIS receive FDA 510(k) clearance?

EXACTECH BIPOLAR HIP PROSTHESIS received FDA 510(k) clearance on 1991-02-27, under 510(k) number K905370.

Who is the listed applicant for EXACTECH BIPOLAR HIP PROSTHESIS?

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 BIPOLAR HIP PROSTHESIS?

The FDA product code for EXACTECH BIPOLAR HIP PROSTHESIS 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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