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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 the device name listed in this FDA 510(k) record. The listed applicant is Exactech, Inc.. It received FDA 510(k) clearance on 2024-10-03 under 510(k) 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. The listed applicant is Exactech, Inc.. The 510(k) number is K240393.

When did Exactech® TRULIANT® Knee System receive FDA 510(k) clearance?

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

Who is the listed applicant for Exactech® TRULIANT® Knee System?

The FDA 510(k) record lists Exactech, Inc. as the applicant. This does not by itself establish the device manufacturer.

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

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

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Related Devices (Code: MBH)

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

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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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