FDA 510(k)

初始膝關節系統

K 號：K243295 · 2025-01-13

決定日期2025-01-13

產品代碼JWH

諮詢委員會或

決定相當於

器材摘要

Initia 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 2025-01-13 under 510(k) number K243295. The device is classified under product code JWH. It was reviewed by the OR advisory panel. FDA Decision: Substantially Equivalent.

常見問題

What is the Initia Knee System?

Initia Knee System is a medical device that received FDA 510(k) clearance on 2025-01-13. The listed applicant is Kyocera Medical Technologies, Inc.. The 510(k) number is K243295.

When did Initia Knee System receive FDA 510(k) clearance?

Initia Knee System received FDA 510(k) clearance on 2025-01-13, under 510(k) number K243295.

Who is the listed applicant for Initia 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 Initia Knee System?

The FDA product code for Initia Knee System is JWH.

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 K243015Skyway前方颈椎板系統 K232114TRIBRID® 閃光單間室膝關節系統

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相關器械（代碼：JWH）

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。

K262057GMK 扩充設備Medacta International SA K260063GSPE 分隔器The General Hospital Corporation, d/b/a Massachusetts K262293EVOLUTION MPX™ 全膝系統Suzhou Microport Orthorecon Co., Ltd.K262341b-ONE® Mobio™ 全膝系統修復水泥固定胫骨增強器、樹枝擴展和壓入式樹枝擴展B-One Ortho, Corp.K262130ATTUNE Revision Knee SystemDepuy Orthopaedics, Inc.K253961SK膝關節系統Just Medical Devices (Tianjin) Co., Ltd.

官方來源

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資料來源為 FDA Open API。如需最新且權威的資訊，請始終參閱官方記錄。