FDA 510(k)

GENESIS UNICONDYLAR UHMWPE ARTICULAR INSERTS

K-Number: K100197 · 2010-02-19

Decision Date2010-02-19

Product CodeHSX

Advisory CommitteeOR

DecisionSubstantially Equivalent

Device Summary

GENESIS UNICONDYLAR UHMWPE ARTICULAR INSERTS is the device name listed in this FDA 510(k) record. The listed applicant is Smith & Nephew, Inc.. It received FDA 510(k) clearance on 2010-02-19 under 510(k) number K100197. 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 GENESIS UNICONDYLAR UHMWPE ARTICULAR INSERTS?

GENESIS UNICONDYLAR UHMWPE ARTICULAR INSERTS is a medical device that received FDA 510(k) clearance on 2010-02-19. The listed applicant is Smith & Nephew, Inc.. The 510(k) number is K100197.

When did GENESIS UNICONDYLAR UHMWPE ARTICULAR INSERTS receive FDA 510(k) clearance?

GENESIS UNICONDYLAR UHMWPE ARTICULAR INSERTS received FDA 510(k) clearance on 2010-02-19, under 510(k) number K100197.

Who is the listed applicant for GENESIS UNICONDYLAR UHMWPE ARTICULAR INSERTS?

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

What is the FDA product code for GENESIS UNICONDYLAR UHMWPE ARTICULAR INSERTS?

The FDA product code for GENESIS UNICONDYLAR UHMWPE ARTICULAR INSERTS is HSX.

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Official Source

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Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.