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FDA 510(k)

TOTAL SHOULDER PROSTHESIS POLYETHYLENE GLENOIND CO

K-Number: K905580 · 1991-03-12

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

Device Summary

TOTAL SHOULDER PROSTHESIS POLYETHYLENE GLENOIND CO 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 K905580. 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 TOTAL SHOULDER PROSTHESIS POLYETHYLENE GLENOIND CO?

TOTAL SHOULDER PROSTHESIS POLYETHYLENE GLENOIND CO 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 K905580.

When did TOTAL SHOULDER PROSTHESIS POLYETHYLENE GLENOIND CO receive FDA 510(k) clearance?

TOTAL SHOULDER PROSTHESIS POLYETHYLENE GLENOIND CO received FDA 510(k) clearance on 1991-03-12, under 510(k) number K905580.

Who is the listed applicant for TOTAL SHOULDER PROSTHESIS POLYETHYLENE GLENOIND CO?

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 TOTAL SHOULDER PROSTHESIS POLYETHYLENE GLENOIND CO?

The FDA product code for TOTAL SHOULDER PROSTHESIS POLYETHYLENE GLENOIND CO 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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