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FDA 510(k)

Optetrak Advanced Patella

K-Number: K160484 · 2016-03-18

ApplicantExactech, Inc.
Decision Date2016-03-18
Product CodeJWH
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

Optetrak Advanced Patella is a medical device manufactured by Exactech, Inc.. It received FDA 510(k) clearance on 2016-03-18 under approval number K160484. 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 Advanced Patella?

Optetrak Advanced Patella is a medical device that received FDA 510(k) clearance on 2016-03-18. It is manufactured by Exactech, Inc.. The 510(k) number is K160484.

When was Optetrak Advanced Patella approved by the FDA?

Optetrak Advanced Patella received FDA 510(k) clearance on 2016-03-18, under approval number K160484.

What company makes Optetrak Advanced Patella?

Optetrak Advanced Patella is manufactured by Exactech, Inc..

What is the FDA product code for Optetrak Advanced Patella?

The FDA product code for Optetrak Advanced Patella 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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