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FDA 510(k)

HEMI-SHOULDER PROSTHESIS

K-Number: K950594 · 1995-05-22

ApplicantEncore Orthopedics, Inc.
Decision Date1995-05-22
Product CodeHSD
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

HEMI-SHOULDER PROSTHESIS is the device name listed in this FDA 510(k) record. The listed applicant is Encore Orthopedics, Inc.. It received FDA 510(k) clearance on 1995-05-22 under 510(k) number K950594. 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 HEMI-SHOULDER PROSTHESIS?

HEMI-SHOULDER PROSTHESIS is a medical device that received FDA 510(k) clearance on 1995-05-22. The listed applicant is Encore Orthopedics, Inc.. The 510(k) number is K950594.

When did HEMI-SHOULDER PROSTHESIS receive FDA 510(k) clearance?

HEMI-SHOULDER PROSTHESIS received FDA 510(k) clearance on 1995-05-22, under 510(k) number K950594.

Who is the listed applicant for HEMI-SHOULDER PROSTHESIS?

The FDA 510(k) record lists Encore Orthopedics, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for HEMI-SHOULDER PROSTHESIS?

The FDA product code for HEMI-SHOULDER PROSTHESIS is 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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