FDA 510(k)

COMPETITOR UNICONDYLAR KNEE TIBIAL BASEPLATE

K-Number: K061011 · 2006-07-11

Decision Date2006-07-11

Product CodeHSX

Advisory CommitteeOR

DecisionSubstantially Equivalent

Device Summary

COMPETITOR UNICONDYLAR KNEE 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 2006-07-11 under 510(k) number K061011. 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 KNEE TIBIAL BASEPLATE?

COMPETITOR UNICONDYLAR KNEE TIBIAL BASEPLATE is a medical device that received FDA 510(k) clearance on 2006-07-11. The listed applicant is Smith & Nephew, Inc.. The 510(k) number is K061011.

When did COMPETITOR UNICONDYLAR KNEE TIBIAL BASEPLATE receive FDA 510(k) clearance?

COMPETITOR UNICONDYLAR KNEE TIBIAL BASEPLATE received FDA 510(k) clearance on 2006-07-11, under 510(k) number K061011.

Who is the listed applicant for COMPETITOR UNICONDYLAR KNEE 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 KNEE TIBIAL BASEPLATE?

The FDA product code for COMPETITOR UNICONDYLAR KNEE TIBIAL BASEPLATE is HSX.

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Other records listing Smith & Nephew, Inc. as applicant

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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.