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FDA 510(k)

Cemented Tibia Baseplate no Taper with JRNY Lock

K-Number: K230555 · 2023-03-30

ApplicantSmith & Nephew, Inc.
Decision Date2023-03-30
Product CodeJWH
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

Cemented Tibia Baseplate no Taper with JRNY Lock is a medical device manufactured by Smith & Nephew, Inc.. It received FDA 510(k) clearance on 2023-03-30 under approval number K230555. 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 Cemented Tibia Baseplate no Taper with JRNY Lock?

Cemented Tibia Baseplate no Taper with JRNY Lock is a medical device that received FDA 510(k) clearance on 2023-03-30. It is manufactured by Smith & Nephew, Inc.. The 510(k) number is K230555.

When was Cemented Tibia Baseplate no Taper with JRNY Lock approved by the FDA?

Cemented Tibia Baseplate no Taper with JRNY Lock received FDA 510(k) clearance on 2023-03-30, under approval number K230555.

What company makes Cemented Tibia Baseplate no Taper with JRNY Lock?

Cemented Tibia Baseplate no Taper with JRNY Lock is manufactured by Smith & Nephew, Inc..

What is the FDA product code for Cemented Tibia Baseplate no Taper with JRNY Lock?

The FDA product code for Cemented Tibia Baseplate no Taper with JRNY Lock 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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