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FDA 510(k)

EXACTECH HUMERAL SHOULDER PROSTHESIS

K-Number: K905577 · 1991-03-12

ApplicantExactech, Inc.
Decision Date1991-03-12
Product CodeHSD
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

EXACTECH HUMERAL SHOULDER 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 1991-03-12 under 510(k) number K905577. The device is classified under product code HSD. It was reviewed by the OR advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the EXACTECH HUMERAL SHOULDER PROSTHESIS?

EXACTECH HUMERAL SHOULDER PROSTHESIS is a medical device that received FDA 510(k) clearance on 1991-03-12. The listed applicant is Exactech, Inc.. The 510(k) number is K905577.

When did EXACTECH HUMERAL SHOULDER PROSTHESIS receive FDA 510(k) clearance?

EXACTECH HUMERAL SHOULDER PROSTHESIS received FDA 510(k) clearance on 1991-03-12, under 510(k) number K905577.

Who is the listed applicant for EXACTECH HUMERAL SHOULDER 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 HUMERAL SHOULDER PROSTHESIS?

The FDA product code for EXACTECH HUMERAL SHOULDER PROSTHESIS is HSD.

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Related Devices (Code: HSD)

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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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