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FDA 510(k)

Journey II XR Knee Instrument

K-Number: K200227 · 2020-06-04

ApplicantSmith & Nephew, Inc.
Decision Date2020-06-04
Product CodeJWH
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

Journey II XR Knee Instrument is a medical device manufactured by Smith & Nephew, Inc.. It received FDA 510(k) clearance on 2020-06-04 under approval number K200227. The device is classified under product code JWH. It was reviewed by the OR advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Journey II XR Knee Instrument?

Journey II XR Knee Instrument is a medical device that received FDA 510(k) clearance on 2020-06-04. It is manufactured by Smith & Nephew, Inc.. The 510(k) number is K200227.

When was Journey II XR Knee Instrument approved by the FDA?

Journey II XR Knee Instrument received FDA 510(k) clearance on 2020-06-04, under approval number K200227.

What company makes Journey II XR Knee Instrument?

Journey II XR Knee Instrument is manufactured by Smith & Nephew, Inc..

What is the FDA product code for Journey II XR Knee Instrument?

The FDA product code for Journey II XR Knee Instrument is JWH.

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Related Devices (Code: JWH)

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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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