FDA 510(k)

JOURNEY UNICONDYLAR TIBIAL BASEPLATES

K-Number: K102069 · 2010-10-05

Decision Date2010-10-05

Product CodeHSX

Advisory CommitteeOR

DecisionSubstantially Equivalent

Device Summary

JOURNEY UNICONDYLAR TIBIAL BASEPLATES 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 2010-10-05 under 510(k) number K102069. 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 JOURNEY UNICONDYLAR TIBIAL BASEPLATES?

JOURNEY UNICONDYLAR TIBIAL BASEPLATES is a medical device that received FDA 510(k) clearance on 2010-10-05. The listed applicant is Smith & Nephew, Inc.. The 510(k) number is K102069.

When did JOURNEY UNICONDYLAR TIBIAL BASEPLATES receive FDA 510(k) clearance?

JOURNEY UNICONDYLAR TIBIAL BASEPLATES received FDA 510(k) clearance on 2010-10-05, under 510(k) number K102069.

Who is the listed applicant for JOURNEY UNICONDYLAR TIBIAL BASEPLATES?

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 JOURNEY UNICONDYLAR TIBIAL BASEPLATES?

The FDA product code for JOURNEY UNICONDYLAR TIBIAL BASEPLATES 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.