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FDA 510(k)

Journey II Mid-Level Tibial Inserts

K-Number: K211671 · 2021-08-17

ApplicantSmith & Nephew, Inc.
Decision Date2021-08-17
Product CodeJWH
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

Journey II Mid-Level Tibial Inserts is a medical device manufactured by Smith & Nephew, Inc.. It received FDA 510(k) clearance on 2021-08-17 under approval number K211671. 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 Mid-Level Tibial Inserts?

Journey II Mid-Level Tibial Inserts is a medical device that received FDA 510(k) clearance on 2021-08-17. It is manufactured by Smith & Nephew, Inc.. The 510(k) number is K211671.

When was Journey II Mid-Level Tibial Inserts approved by the FDA?

Journey II Mid-Level Tibial Inserts received FDA 510(k) clearance on 2021-08-17, under approval number K211671.

What company makes Journey II Mid-Level Tibial Inserts?

Journey II Mid-Level Tibial Inserts is manufactured by Smith & Nephew, Inc..

What is the FDA product code for Journey II Mid-Level Tibial Inserts?

The FDA product code for Journey II Mid-Level Tibial Inserts is 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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