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FDA 510(k)

OPTETRAK CONSTRAINED CONDYLAR KNEE FOR CEMENTED USE ONLY

K-Number: K954208 · 1996-02-26

ApplicantExactech, Inc.
Decision Date1996-02-26
Product CodeJWH
Advisory CommitteeOR
DecisionSubstantially Equivalent for Some Indications

Device Summary

OPTETRAK CONSTRAINED CONDYLAR KNEE FOR CEMENTED USE ONLY is the device name listed in this FDA 510(k) record. The listed applicant is Exactech, Inc.. It received FDA 510(k) clearance on 1996-02-26 under 510(k) number K954208. The device is classified under product code JWH. It was reviewed by the OR advisory panel. FDA Decision: Substantially Equivalent for Some Indications.

Frequently Asked Questions

What is the OPTETRAK CONSTRAINED CONDYLAR KNEE FOR CEMENTED USE ONLY?

OPTETRAK CONSTRAINED CONDYLAR KNEE FOR CEMENTED USE ONLY is a medical device that received FDA 510(k) clearance on 1996-02-26. The listed applicant is Exactech, Inc.. The 510(k) number is K954208.

When did OPTETRAK CONSTRAINED CONDYLAR KNEE FOR CEMENTED USE ONLY receive FDA 510(k) clearance?

OPTETRAK CONSTRAINED CONDYLAR KNEE FOR CEMENTED USE ONLY received FDA 510(k) clearance on 1996-02-26, under 510(k) number K954208.

Who is the listed applicant for OPTETRAK CONSTRAINED CONDYLAR KNEE FOR CEMENTED USE ONLY?

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 CONSTRAINED CONDYLAR KNEE FOR CEMENTED USE ONLY?

The FDA product code for OPTETRAK CONSTRAINED CONDYLAR KNEE FOR CEMENTED USE ONLY is JWH.

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Related Devices (Code: JWH)

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.

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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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