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FDA 510(k)

OPTETRAK LOGIC CRC TIBIAL INSERT

K-Number: K123342 · 2013-01-10

ApplicantExactech, Inc.
Decision Date2013-01-10
Product CodeJWH
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

OPTETRAK LOGIC CRC TIBIAL INSERT is the device name listed in this FDA 510(k) record. The listed applicant is Exactech, Inc.. It received FDA 510(k) clearance on 2013-01-10 under 510(k) number K123342. 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 OPTETRAK LOGIC CRC TIBIAL INSERT?

OPTETRAK LOGIC CRC TIBIAL INSERT is a medical device that received FDA 510(k) clearance on 2013-01-10. The listed applicant is Exactech, Inc.. The 510(k) number is K123342.

When did OPTETRAK LOGIC CRC TIBIAL INSERT receive FDA 510(k) clearance?

OPTETRAK LOGIC CRC TIBIAL INSERT received FDA 510(k) clearance on 2013-01-10, under 510(k) number K123342.

Who is the listed applicant for OPTETRAK LOGIC CRC TIBIAL INSERT?

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 OPTETRAK LOGIC CRC TIBIAL INSERT?

The FDA product code for OPTETRAK LOGIC CRC TIBIAL INSERT is JWH.

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Related Devices (Code: 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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