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FDA 510(k)

Klassic® Tibial Insert, PS-Post, Klassic All Poly Tibia, PS-Post

K-Number: K232414 · 2023-09-08

ApplicantTotal Joint Othopedics, Inc.
Decision Date2023-09-08
Product CodeJWH
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

Klassic® Tibial Insert, PS-Post, Klassic All Poly Tibia, PS-Post is a medical device manufactured by Total Joint Othopedics, Inc.. It received FDA 510(k) clearance on 2023-09-08 under approval number K232414. 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 Klassic® Tibial Insert, PS-Post, Klassic All Poly Tibia, PS-Post?

Klassic® Tibial Insert, PS-Post, Klassic All Poly Tibia, PS-Post is a medical device that received FDA 510(k) clearance on 2023-09-08. It is manufactured by Total Joint Othopedics, Inc.. The 510(k) number is K232414.

When was Klassic® Tibial Insert, PS-Post, Klassic All Poly Tibia, PS-Post approved by the FDA?

Klassic® Tibial Insert, PS-Post, Klassic All Poly Tibia, PS-Post received FDA 510(k) clearance on 2023-09-08, under approval number K232414.

What company makes Klassic® Tibial Insert, PS-Post, Klassic All Poly Tibia, PS-Post?

Klassic® Tibial Insert, PS-Post, Klassic All Poly Tibia, PS-Post is manufactured by Total Joint Othopedics, Inc..

What is the FDA product code for Klassic® Tibial Insert, PS-Post, Klassic All Poly Tibia, PS-Post?

The FDA product code for Klassic® Tibial Insert, PS-Post, Klassic All Poly Tibia, PS-Post is JWH.

Related Clinical Trials

NCT06636136 Transtibial Osseointegration RECRUITING

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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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