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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 the device name listed in this FDA 510(k) record. The listed applicant is Exactech, Inc.. It received FDA 510(k) clearance on 2016-03-10 under 510(k) 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. The listed applicant is Exactech, Inc.. The 510(k) number is K153776.

When did Optetrak One Logic Femoral Components receive FDA 510(k) clearance?

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

Who is the listed applicant for Optetrak One Logic Femoral Components?

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 One Logic Femoral Components?

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

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Related Devices (Code: MBH)

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

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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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