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FDA 510(k)

OPTERTRAK LOGIC PSC TIBIAL INSERT

K-Number: K110547 · 2011-04-14

ApplicantExactech Sarasota
Decision Date2011-04-14
Product CodeJWH
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

OPTERTRAK LOGIC PSC TIBIAL INSERT is the device name listed in this FDA 510(k) record. The listed applicant is Exactech Sarasota. It received FDA 510(k) clearance on 2011-04-14 under 510(k) number K110547. 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 OPTERTRAK LOGIC PSC TIBIAL INSERT?

OPTERTRAK LOGIC PSC TIBIAL INSERT is a medical device that received FDA 510(k) clearance on 2011-04-14. The listed applicant is Exactech Sarasota. The 510(k) number is K110547.

When did OPTERTRAK LOGIC PSC TIBIAL INSERT receive FDA 510(k) clearance?

OPTERTRAK LOGIC PSC TIBIAL INSERT received FDA 510(k) clearance on 2011-04-14, under 510(k) number K110547.

Who is the listed applicant for OPTERTRAK LOGIC PSC TIBIAL INSERT?

The FDA 510(k) record lists Exactech Sarasota as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for OPTERTRAK LOGIC PSC TIBIAL INSERT?

The FDA product code for OPTERTRAK LOGIC PSC TIBIAL INSERT 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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