FDA 510(k)

COMPETITOR UNICONDYLAR ALL-POLY TIBIAL BASEPLATE

K-Number: K061779 · 2006-08-04

Decision Date2006-08-04

Product CodeHSX

Advisory CommitteeOR

DecisionSubstantially Equivalent

Device Summary

COMPETITOR UNICONDYLAR ALL-POLY TIBIAL BASEPLATE 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 2006-08-04 under 510(k) number K061779. 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 COMPETITOR UNICONDYLAR ALL-POLY TIBIAL BASEPLATE?

COMPETITOR UNICONDYLAR ALL-POLY TIBIAL BASEPLATE is a medical device that received FDA 510(k) clearance on 2006-08-04. The listed applicant is Smith & Nephew, Inc.. The 510(k) number is K061779.

When did COMPETITOR UNICONDYLAR ALL-POLY TIBIAL BASEPLATE receive FDA 510(k) clearance?

COMPETITOR UNICONDYLAR ALL-POLY TIBIAL BASEPLATE received FDA 510(k) clearance on 2006-08-04, under 510(k) number K061779.

Who is the listed applicant for COMPETITOR UNICONDYLAR ALL-POLY TIBIAL BASEPLATE?

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 COMPETITOR UNICONDYLAR ALL-POLY TIBIAL BASEPLATE?

The FDA product code for COMPETITOR UNICONDYLAR ALL-POLY TIBIAL BASEPLATE 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.