FDA 510(k)

UNICONDYLAR FEMORAL COMPONENT

K-Number: K030301 · 2003-02-25

Decision Date2003-02-25

Product CodeJWH

Advisory CommitteeOR

DecisionSubstantially Equivalent

Device Summary

UNICONDYLAR FEMORAL COMPONENT 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 2003-02-25 under 510(k) number K030301. The device is classified under product code JWH. It was reviewed by the OR advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the UNICONDYLAR FEMORAL COMPONENT?

UNICONDYLAR FEMORAL COMPONENT is a medical device that received FDA 510(k) clearance on 2003-02-25. The listed applicant is Smith & Nephew, Inc.. The 510(k) number is K030301.

When did UNICONDYLAR FEMORAL COMPONENT receive FDA 510(k) clearance?

UNICONDYLAR FEMORAL COMPONENT received FDA 510(k) clearance on 2003-02-25, under 510(k) number K030301.

Who is the listed applicant for UNICONDYLAR FEMORAL COMPONENT?

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 UNICONDYLAR FEMORAL COMPONENT?

The FDA product code for UNICONDYLAR FEMORAL COMPONENT is JWH.

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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.