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FDA 510(k)

Journey II Unicompartmental Knee System

K-Number: K190085 · 2019-02-11

ApplicantSmith & Nephew, Inc.
Decision Date2019-02-11
Product CodeHSX
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

Journey II Unicompartmental Knee System is a medical device manufactured by Smith & Nephew, Inc.. It received FDA 510(k) clearance on 2019-02-11 under approval number K190085. 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 II Unicompartmental Knee System?

Journey II Unicompartmental Knee System is a medical device that received FDA 510(k) clearance on 2019-02-11. It is manufactured by Smith & Nephew, Inc.. The 510(k) number is K190085.

When was Journey II Unicompartmental Knee System approved by the FDA?

Journey II Unicompartmental Knee System received FDA 510(k) clearance on 2019-02-11, under approval number K190085.

What company makes Journey II Unicompartmental Knee System?

Journey II Unicompartmental Knee System is manufactured by Smith & Nephew, Inc..

What is the FDA product code for Journey II Unicompartmental Knee System?

The FDA product code for Journey II Unicompartmental Knee System is HSX.

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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.

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