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FDA 510(k)

TRIATHLON CS (CONDYLAR STABILIZING) LIPPED INSERT

K-Number: K063423 · 2007-01-22

ApplicantHowmedica Osteonics
Decision Date2007-01-22
Product CodeJWH
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

TRIATHLON CS (CONDYLAR STABILIZING) LIPPED INSERT is the device name listed in this FDA 510(k) record. The listed applicant is Howmedica Osteonics. It received FDA 510(k) clearance on 2007-01-22 under 510(k) number K063423. 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 CS (CONDYLAR STABILIZING) LIPPED INSERT?

TRIATHLON CS (CONDYLAR STABILIZING) LIPPED INSERT is a medical device that received FDA 510(k) clearance on 2007-01-22. The listed applicant is Howmedica Osteonics. The 510(k) number is K063423.

When did TRIATHLON CS (CONDYLAR STABILIZING) LIPPED INSERT receive FDA 510(k) clearance?

TRIATHLON CS (CONDYLAR STABILIZING) LIPPED INSERT received FDA 510(k) clearance on 2007-01-22, under 510(k) number K063423.

Who is the listed applicant for TRIATHLON CS (CONDYLAR STABILIZING) LIPPED INSERT?

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

What is the FDA product code for TRIATHLON CS (CONDYLAR STABILIZING) LIPPED INSERT?

The FDA product code for TRIATHLON CS (CONDYLAR STABILIZING) LIPPED 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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