FDA 510(k)

TRIBRID® 閃光單間室膝關節系統

K 號：K232114 · 2024-04-04

決定日期2024-04-04

產品代碼HSX

諮詢委員會或

決定相當於

器材摘要

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.

常見問題

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?

FDA 510(k) 記錄將京瓷醫療技術股份有限公司列為申請人。這並不單獨確立設備製造商。

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

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

其他以 Kyocera Medical Technologies, Inc. 為申請人之記錄

相關紀錄係使用名稱、產品代碼或其他後設資料自動配對。配對結果並不構成已驗證的臨床、科學、企業或監管關係，請查閱連結的官方來源。

K261353泰瑟拉-K 前腰椎間融合（ALIF）系統；泰瑟拉-K XL 系統；腰椎固定系統 K242045初始T3骨盂半球形殼系統 K242928泰瑟拉-k SC 系統 K242771泰瑟拉-k PL系統及泰瑟拉-k XL系統 K243295初始膝關節系統 K243015Skyway前方颈椎板系統

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相關器械（代碼：HSX）

相關紀錄係使用名稱、產品代碼或其他後設資料自動配對。配對結果並不構成已驗證的臨床、科學、企業或監管關係，請查閱連結的官方來源。

K261609自由部分膝關節系統Maxx Orthopedics, Inc.K260796塔霍聯合單關節膝關節系統，配以TiNbN覆層Shalby Advanced Technologies, Inc. Dba Consensus Orthopedics K251771卡麥遜部分膝關節Signature Orthopaedics Pty, Ltd.K251834人體部分膝蓋Zimmer Biomet K251618MOTO 部分膝關節系統擴充版Medacta International S.A.K251453Arthrex iBalance 部分膝關節系統Arthrex, Inc.

官方來源

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