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FDA 510(k)

Optetrak Logic Metaphyseal Cones

K-Number: K153595 · 2016-03-25

ApplicantExactech, Inc.
Decision Date2016-03-25
Product CodeJWH
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

Optetrak Logic Metaphyseal Cones is the device name listed in this FDA 510(k) record. The listed applicant is Exactech, Inc.. It received FDA 510(k) clearance on 2016-03-25 under 510(k) number K153595. 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 Metaphyseal Cones?

Optetrak Logic Metaphyseal Cones is a medical device that received FDA 510(k) clearance on 2016-03-25. The listed applicant is Exactech, Inc.. The 510(k) number is K153595.

When did Optetrak Logic Metaphyseal Cones receive FDA 510(k) clearance?

Optetrak Logic Metaphyseal Cones received FDA 510(k) clearance on 2016-03-25, under 510(k) number K153595.

Who is the listed applicant for Optetrak Logic Metaphyseal Cones?

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 Metaphyseal Cones?

The FDA product code for Optetrak Logic Metaphyseal Cones 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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