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FDA 510(k)

TRULIANT® E-PX Tibial Inserts; TRULIANT® E-PX Patellas

K-Number: K223252 · 2023-07-17

ApplicantExactech, Inc.
Decision Date2023-07-17
Product CodeJWH
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

TRULIANT® E-PX Tibial Inserts; TRULIANT® E-PX Patellas is a medical device manufactured by Exactech, Inc.. It received FDA 510(k) clearance on 2023-07-17 under approval number K223252. 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 TRULIANT® E-PX Tibial Inserts; TRULIANT® E-PX Patellas?

TRULIANT® E-PX Tibial Inserts; TRULIANT® E-PX Patellas is a medical device that received FDA 510(k) clearance on 2023-07-17. It is manufactured by Exactech, Inc.. The 510(k) number is K223252.

When was TRULIANT® E-PX Tibial Inserts; TRULIANT® E-PX Patellas approved by the FDA?

TRULIANT® E-PX Tibial Inserts; TRULIANT® E-PX Patellas received FDA 510(k) clearance on 2023-07-17, under approval number K223252.

What company makes TRULIANT® E-PX Tibial Inserts; TRULIANT® E-PX Patellas?

TRULIANT® E-PX Tibial Inserts; TRULIANT® E-PX Patellas is manufactured by Exactech, Inc..

What is the FDA product code for TRULIANT® E-PX Tibial Inserts; TRULIANT® E-PX Patellas?

The FDA product code for TRULIANT® E-PX Tibial Inserts; TRULIANT® E-PX Patellas 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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