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FDA 510(k)

SIZE 1 TRIATHLON CRUCIATE RETAINING (CR) TIBIAL INSERT

K-Number: K042883 · 2004-11-23

ApplicantHowmedica Osteonics Corp.
Decision Date2004-11-23
Product CodeJWH
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

SIZE 1 TRIATHLON CRUCIATE RETAINING (CR) TIBIAL INSERT 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 2004-11-23 under 510(k) number K042883. 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 SIZE 1 TRIATHLON CRUCIATE RETAINING (CR) TIBIAL INSERT?

SIZE 1 TRIATHLON CRUCIATE RETAINING (CR) TIBIAL INSERT is a medical device that received FDA 510(k) clearance on 2004-11-23. The listed applicant is Howmedica Osteonics Corp.. The 510(k) number is K042883.

When did SIZE 1 TRIATHLON CRUCIATE RETAINING (CR) TIBIAL INSERT receive FDA 510(k) clearance?

SIZE 1 TRIATHLON CRUCIATE RETAINING (CR) TIBIAL INSERT received FDA 510(k) clearance on 2004-11-23, under 510(k) number K042883.

Who is the listed applicant for SIZE 1 TRIATHLON CRUCIATE RETAINING (CR) TIBIAL INSERT?

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 SIZE 1 TRIATHLON CRUCIATE RETAINING (CR) TIBIAL INSERT?

The FDA product code for SIZE 1 TRIATHLON CRUCIATE RETAINING (CR) 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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