FDA 510(k)

TRIBRID® Unicompartmental Knee System

Número K: K232114 · 2024-04-04

RequerenteKyocera Medical Technologies, Inc.

Data da decisão2024-04-04

Código do produtoHSX

Comité consultivoOR

DecisãoSubstantially Equivalent

Resumo do dispositivo

TRIBRID® Unicompartmental Knee System is the device name listed in this FDA 510(k) record. The listed applicant is Kyocera Medical Technologies, Inc.. It received FDA 510(k) clearance on 2024-04-04 under 510(k) number K232114. The device is classified under product code HSX. It was reviewed by the OR advisory panel. FDA Decision: Substantially Equivalent.

Perguntas frequentes

What is the TRIBRID® Unicompartmental Knee System?

TRIBRID® Unicompartmental Knee System is a medical device that received FDA 510(k) clearance on 2024-04-04. The listed applicant is Kyocera Medical Technologies, Inc.. The 510(k) number is K232114.

When did TRIBRID® Unicompartmental Knee System receive FDA 510(k) clearance?

TRIBRID® Unicompartmental Knee System received FDA 510(k) clearance on 2024-04-04, under 510(k) number K232114.

Who is the listed applicant for TRIBRID® Unicompartmental Knee System?

The FDA 510(k) record lists Kyocera Medical Technologies, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for TRIBRID® Unicompartmental Knee System?

The FDA product code for TRIBRID® Unicompartmental Knee System is HSX.

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Fonte oficial

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