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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 the device name listed in this FDA 510(k) record. The listed applicant is Exactech, Inc.. It received FDA 510(k) clearance on 2016-03-18 under 510(k) 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. The listed applicant is Exactech, Inc.. The 510(k) number is K160484.

When did Optetrak Advanced Patella receive FDA 510(k) clearance?

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

Who is the listed applicant for Optetrak Advanced Patella?

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 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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