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FDA 510(k)

Exactech® TRULIANT® Knee System

K-Number: K240393 · 2024-10-03

ApplicantExactech, Inc.
Decision Date2024-10-03
Product CodeMBH
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

Exactech® TRULIANT® Knee System is a medical device manufactured by Exactech, Inc.. It received FDA 510(k) clearance on 2024-10-03 under approval number K240393. The device is classified under product code MBH. It was reviewed by the OR advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Exactech® TRULIANT® Knee System?

Exactech® TRULIANT® Knee System is a medical device that received FDA 510(k) clearance on 2024-10-03. It is manufactured by Exactech, Inc.. The 510(k) number is K240393.

When was Exactech® TRULIANT® Knee System approved by the FDA?

Exactech® TRULIANT® Knee System received FDA 510(k) clearance on 2024-10-03, under approval number K240393.

What company makes Exactech® TRULIANT® Knee System?

Exactech® TRULIANT® Knee System is manufactured by Exactech, Inc..

What is the FDA product code for Exactech® TRULIANT® Knee System?

The FDA product code for Exactech® TRULIANT® Knee System is MBH.

Other Devices by Exactech, Inc.

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Related Devices (Code: MBH)

K162256Klassic Femur, Porous, Klassic Tibial Baseplate, PorousTotal Joint Orthopedics, Inc. K153657Vanguard XP Knee SystemBiomet, Inc. K153776Optetrak One Logic Femoral ComponentsExactech, Inc. K153586Arthrex iBalance TKA SystemArthrex, Inc. K172634Triathlon® X3® UHMWPE Tibial Inserts and Patellar ComponentsHowmedica Osteonics Corp. A.K.A. Stryker Orthopaedics K171365Arthrex Knee SystemsArthrex, Inc.

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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