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FDA 510(k)

OPTETRAK LOGIC COMBINATION TIBIAL TRAY

K-Number: K101981 · 2010-08-02

ApplicantExactech, Inc.
Decision Date2010-08-02
Product CodeJWH
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

OPTETRAK LOGIC COMBINATION TIBIAL TRAY is the device name listed in this FDA 510(k) record. The listed applicant is Exactech, Inc.. It received FDA 510(k) clearance on 2010-08-02 under 510(k) number K101981. 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 COMBINATION TIBIAL TRAY?

OPTETRAK LOGIC COMBINATION TIBIAL TRAY is a medical device that received FDA 510(k) clearance on 2010-08-02. The listed applicant is Exactech, Inc.. The 510(k) number is K101981.

When did OPTETRAK LOGIC COMBINATION TIBIAL TRAY receive FDA 510(k) clearance?

OPTETRAK LOGIC COMBINATION TIBIAL TRAY received FDA 510(k) clearance on 2010-08-02, under 510(k) number K101981.

Who is the listed applicant for OPTETRAK LOGIC COMBINATION TIBIAL TRAY?

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 COMBINATION TIBIAL TRAY?

The FDA product code for OPTETRAK LOGIC COMBINATION TIBIAL TRAY 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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