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FDA 510(k)

TRIATHLON CRUCIATE RETAINING (CR) TOTAL KNEE

K-Number: K040267 · 2004-05-05

ApplicantHowmedica Osteonics Corp.
Decision Date2004-05-05
Product CodeJWH
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

TRIATHLON CRUCIATE RETAINING (CR) TOTAL KNEE is the device name listed in this FDA 510(k) record. The listed applicant is Howmedica Osteonics Corp.. It received FDA 510(k) clearance on 2004-05-05 under 510(k) number K040267. 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 TRIATHLON CRUCIATE RETAINING (CR) TOTAL KNEE?

TRIATHLON CRUCIATE RETAINING (CR) TOTAL KNEE is a medical device that received FDA 510(k) clearance on 2004-05-05. The listed applicant is Howmedica Osteonics Corp.. The 510(k) number is K040267.

When did TRIATHLON CRUCIATE RETAINING (CR) TOTAL KNEE receive FDA 510(k) clearance?

TRIATHLON CRUCIATE RETAINING (CR) TOTAL KNEE received FDA 510(k) clearance on 2004-05-05, under 510(k) number K040267.

Who is the listed applicant for TRIATHLON CRUCIATE RETAINING (CR) TOTAL KNEE?

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

What is the FDA product code for TRIATHLON CRUCIATE RETAINING (CR) TOTAL KNEE?

The FDA product code for TRIATHLON CRUCIATE RETAINING (CR) TOTAL KNEE 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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