FDA 510(k)

OPTETRAK LOGIC CR TIBIAL INSERT, SIZE 0 OPTETRAK LOGIC CR TIBIAL INSERT, SIZE 6 OPTETRAK LOGIC CR FEMORAL COMPONENT, SIZ

K-Number: K121307 · 2012-05-31

Decision Date2012-05-31

Product CodeJWH

Advisory CommitteeOR

DecisionSubstantially Equivalent

Device Summary

OPTETRAK LOGIC CR TIBIAL INSERT, SIZE 0 OPTETRAK LOGIC CR TIBIAL INSERT, SIZE 6 OPTETRAK LOGIC CR FEMORAL COMPONENT, SIZ is the device name listed in this FDA 510(k) record. The listed applicant is Exactech, Inc.. It received FDA 510(k) clearance on 2012-05-31 under 510(k) number K121307. 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 CR TIBIAL INSERT, SIZE 0 OPTETRAK LOGIC CR TIBIAL INSERT, SIZE 6 OPTETRAK LOGIC CR FEMORAL COMPONENT, SIZ?

OPTETRAK LOGIC CR TIBIAL INSERT, SIZE 0 OPTETRAK LOGIC CR TIBIAL INSERT, SIZE 6 OPTETRAK LOGIC CR FEMORAL COMPONENT, SIZ is a medical device that received FDA 510(k) clearance on 2012-05-31. The listed applicant is Exactech, Inc.. The 510(k) number is K121307.

When did OPTETRAK LOGIC CR TIBIAL INSERT, SIZE 0 OPTETRAK LOGIC CR TIBIAL INSERT, SIZE 6 OPTETRAK LOGIC CR FEMORAL COMPONENT, SIZ receive FDA 510(k) clearance?

OPTETRAK LOGIC CR TIBIAL INSERT, SIZE 0 OPTETRAK LOGIC CR TIBIAL INSERT, SIZE 6 OPTETRAK LOGIC CR FEMORAL COMPONENT, SIZ received FDA 510(k) clearance on 2012-05-31, under 510(k) number K121307.

Who is the listed applicant for OPTETRAK LOGIC CR TIBIAL INSERT, SIZE 0 OPTETRAK LOGIC CR TIBIAL INSERT, SIZE 6 OPTETRAK LOGIC CR FEMORAL COMPONENT, SIZ?

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 CR TIBIAL INSERT, SIZE 0 OPTETRAK LOGIC CR TIBIAL INSERT, SIZE 6 OPTETRAK LOGIC CR FEMORAL COMPONENT, SIZ?

The FDA product code for OPTETRAK LOGIC CR TIBIAL INSERT, SIZE 0 OPTETRAK LOGIC CR TIBIAL INSERT, SIZE 6 OPTETRAK LOGIC CR FEMORAL COMPONENT, SIZ 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.