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FDA 510(k)

Optetrak One Logic Femoral Components

K-Number: K153776 · 2016-03-10

ApplicantExactech, Inc.
Decision Date2016-03-10
Product CodeMBH
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

Optetrak One Logic Femoral Components is a medical device manufactured by Exactech, Inc.. It received FDA 510(k) clearance on 2016-03-10 under approval number K153776. 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 Optetrak One Logic Femoral Components?

Optetrak One Logic Femoral Components is a medical device that received FDA 510(k) clearance on 2016-03-10. It is manufactured by Exactech, Inc.. The 510(k) number is K153776.

When was Optetrak One Logic Femoral Components approved by the FDA?

Optetrak One Logic Femoral Components received FDA 510(k) clearance on 2016-03-10, under approval number K153776.

What company makes Optetrak One Logic Femoral Components?

Optetrak One Logic Femoral Components is manufactured by Exactech, Inc..

What is the FDA product code for Optetrak One Logic Femoral Components?

The FDA product code for Optetrak One Logic Femoral Components is MBH.

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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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