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FDA 510(k)

EXACTECH OPTETRAK UNICONDYLAR KNEE

K-Number: K040889 · 2004-10-01

ApplicantExactech, Inc.
Decision Date2004-10-01
Product CodeHRY
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

EXACTECH OPTETRAK UNICONDYLAR KNEE is the device name listed in this FDA 510(k) record. The listed applicant is Exactech, Inc.. It received FDA 510(k) clearance on 2004-10-01 under 510(k) number K040889. The device is classified under product code HRY. It was reviewed by the OR advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the EXACTECH OPTETRAK UNICONDYLAR KNEE?

EXACTECH OPTETRAK UNICONDYLAR KNEE is a medical device that received FDA 510(k) clearance on 2004-10-01. The listed applicant is Exactech, Inc.. The 510(k) number is K040889.

When did EXACTECH OPTETRAK UNICONDYLAR KNEE receive FDA 510(k) clearance?

EXACTECH OPTETRAK UNICONDYLAR KNEE received FDA 510(k) clearance on 2004-10-01, under 510(k) number K040889.

Who is the listed applicant for EXACTECH OPTETRAK UNICONDYLAR KNEE?

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 EXACTECH OPTETRAK UNICONDYLAR KNEE?

The FDA product code for EXACTECH OPTETRAK UNICONDYLAR KNEE is HRY.

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Related Devices (Code: HRY)

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K193549SIGMA High Performance (HP) Partial Knee SystemDepuy Ireland UCK190633NanoOrtho NanoKnee® SystemNanoortho, LLCK152631MPO Total Knee Systems MR LabelingMicroport Orthopedics, Inc.K131167UNIVATIONAesculap Implant Systems, LLCK122277OXFORD FIXED LATERAL BEARING PARTIAL KNEE REPLACEMENT (OXFORD TIBIAL TRAYS A-F) IXFORD PARTIAL KNEE REPLACEMENT SYSTEMBiomet Manufacturing CorpK110415SIGNATURE PLANNER / SIGNATURE GUIDESMaterialise NV

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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