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FDA 510(k)

TRIATHLON LOW PROFILE TIBIAL TRAY

K-Number: K062037 · 2006-08-03

ApplicantHowmedica Osteonics Corp.
Decision Date2006-08-03
Product CodeJWH
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

TRIATHLON LOW PROFILE TIBIAL TRAY 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 2006-08-03 under 510(k) number K062037. 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 LOW PROFILE TIBIAL TRAY?

TRIATHLON LOW PROFILE TIBIAL TRAY is a medical device that received FDA 510(k) clearance on 2006-08-03. The listed applicant is Howmedica Osteonics Corp.. The 510(k) number is K062037.

When did TRIATHLON LOW PROFILE TIBIAL TRAY receive FDA 510(k) clearance?

TRIATHLON LOW PROFILE TIBIAL TRAY received FDA 510(k) clearance on 2006-08-03, under 510(k) number K062037.

Who is the listed applicant for TRIATHLON LOW PROFILE TIBIAL TRAY?

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 LOW PROFILE TIBIAL TRAY?

The FDA product code for TRIATHLON LOW PROFILE TIBIAL TRAY is JWH.

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Related Devices (Code: 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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