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FDA 510(k)

Truliant Porous Femoral Components

K-Number: K181794 · 2018-09-28

ApplicantExactech, Inc.
Decision Date2018-09-28
Product CodeMBH
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

Truliant Porous Femoral Components is a medical device manufactured by Exactech, Inc.. It received FDA 510(k) clearance on 2018-09-28 under approval number K181794. 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 Truliant Porous Femoral Components?

Truliant Porous Femoral Components is a medical device that received FDA 510(k) clearance on 2018-09-28. It is manufactured by Exactech, Inc.. The 510(k) number is K181794.

When was Truliant Porous Femoral Components approved by the FDA?

Truliant Porous Femoral Components received FDA 510(k) clearance on 2018-09-28, under approval number K181794.

What company makes Truliant Porous Femoral Components?

Truliant Porous Femoral Components is manufactured by Exactech, Inc..

What is the FDA product code for Truliant Porous Femoral Components?

The FDA product code for Truliant Porous Femoral Components is MBH.

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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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