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FDA 510(k)

HLS UNI EVOLUTION PROSTHESIS

K-Number: K022211 · 2003-05-22

ApplicantTornier
Decision Date2003-05-22
Product CodeHSX
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

HLS UNI EVOLUTION PROSTHESIS is the device name listed in this FDA 510(k) record. The listed applicant is Tornier. It received FDA 510(k) clearance on 2003-05-22 under 510(k) number K022211. The device is classified under product code HSX. It was reviewed by the OR advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the HLS UNI EVOLUTION PROSTHESIS?

HLS UNI EVOLUTION PROSTHESIS is a medical device that received FDA 510(k) clearance on 2003-05-22. The listed applicant is Tornier. The 510(k) number is K022211.

When did HLS UNI EVOLUTION PROSTHESIS receive FDA 510(k) clearance?

HLS UNI EVOLUTION PROSTHESIS received FDA 510(k) clearance on 2003-05-22, under 510(k) number K022211.

Who is the listed applicant for HLS UNI EVOLUTION PROSTHESIS?

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

What is the FDA product code for HLS UNI EVOLUTION PROSTHESIS?

The FDA product code for HLS UNI EVOLUTION PROSTHESIS is HSX.

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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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