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FDA 510(k)

Truliant Femoral Components

K-Number: K170240 · 2017-02-23

ApplicantExactech, Inc.
Decision Date2017-02-23
Product CodeJWH
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

Truliant Femoral Components is a medical device manufactured by Exactech, Inc.. It received FDA 510(k) clearance on 2017-02-23 under approval number K170240. 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 Femoral Components?

Truliant Femoral Components is a medical device that received FDA 510(k) clearance on 2017-02-23. It is manufactured by Exactech, Inc.. The 510(k) number is K170240.

When was Truliant Femoral Components approved by the FDA?

Truliant Femoral Components received FDA 510(k) clearance on 2017-02-23, under approval number K170240.

What company makes Truliant Femoral Components?

Truliant Femoral Components is manufactured by Exactech, Inc..

What is the FDA product code for Truliant Femoral Components?

The FDA product code for Truliant Femoral Components is JWH.

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Related Devices (Code: JWH)

K160515PS2 Knee SystemConsensus Orthopedics, Inc. K160771Destiknee Total Knee SystemMeril Healthcare Private Limited K160157LOSPA Modular Knee SystemCorentec Co., Ltd. K162273Materialise TKA Guide SystemMaterialise NV K162422Klassic Knee SystemTotal Joint Orthopedics, Inc. K161945EXPRT Revision Knee Femoral Augment(5mm), EXPRT Revision Knee Stem Extension (40mm)Encore Medical L.P.

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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