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FDA 510(k)

Exactech® Truliant™ Line Extensions

K-Number: K171045 · 2017-04-28

ApplicantExactech, Inc.
Decision Date2017-04-28
Product CodeJWH
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

Exactech® Truliant™ Line Extensions is the device name listed in this FDA 510(k) record. The listed applicant is Exactech, Inc.. It received FDA 510(k) clearance on 2017-04-28 under 510(k) number K171045. 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 Exactech® Truliant™ Line Extensions?

Exactech® Truliant™ Line Extensions is a medical device that received FDA 510(k) clearance on 2017-04-28. The listed applicant is Exactech, Inc.. The 510(k) number is K171045.

When did Exactech® Truliant™ Line Extensions receive FDA 510(k) clearance?

Exactech® Truliant™ Line Extensions received FDA 510(k) clearance on 2017-04-28, under 510(k) number K171045.

Who is the listed applicant for Exactech® Truliant™ Line Extensions?

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™ Line Extensions?

The FDA product code for Exactech® Truliant™ Line Extensions 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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