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FDA 510(k)

TRIBRID® Unicompartmental Knee System

K-Number: K232114 · 2024-04-04

ApplicantKyocera Medical Technologies, Inc.
Decision Date2024-04-04
Product CodeHSX
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

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

Frequently Asked Questions

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. It is manufactured by Kyocera Medical Technologies, Inc.. The 510(k) number is K232114.

When was TRIBRID® Unicompartmental Knee System approved by the FDA?

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

What company makes TRIBRID® Unicompartmental Knee System?

TRIBRID® Unicompartmental Knee System is manufactured by Kyocera Medical Technologies, Inc..

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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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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