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FDA 510(k)

JOURNEY II Unicompartmental Knee System

K-Number: K191211 · 2019-07-25

ApplicantSmith & Nephew, Inc.
Decision Date2019-07-25
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 2019-07-25 under approval number K191211. 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 2019-07-25. It is manufactured by Smith & Nephew, Inc.. The 510(k) number is K191211.

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

JOURNEY II Unicompartmental Knee System received FDA 510(k) clearance on 2019-07-25, under approval number K191211.

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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Related PubMed Literature

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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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