FDA 510(k)

京瓷雙極股骨系統

K 號：K200709 · 2020-04-17

決定日期2020-04-17

產品代碼KWY

諮詢委員會或

決定相當於

器材摘要

Kyocera Bipolar Hip 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 2020-04-17 under 510(k) number K200709. The device is classified under product code KWY. It was reviewed by the OR advisory panel. FDA Decision: Substantially Equivalent.

常見問題

What is the Kyocera Bipolar Hip System?

Kyocera Bipolar Hip System is a medical device that received FDA 510(k) clearance on 2020-04-17. The listed applicant is Kyocera Medical Technologies, Inc.. The 510(k) number is K200709.

When did Kyocera Bipolar Hip System receive FDA 510(k) clearance?

Kyocera Bipolar Hip System received FDA 510(k) clearance on 2020-04-17, under 510(k) number K200709.

Who is the listed applicant for Kyocera Bipolar Hip 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 Kyocera Bipolar Hip System?

The FDA product code for Kyocera Bipolar Hip System is KWY.

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 K242928泰瑟拉-k SC 系統 K242045初始T3骨盂半球形殼系統 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：KWY）

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。

K253357b-ONE®雙極頭B-One Ortho, Corp.K243634Maxx Libertas雙極股頭 (雙極股)Maxx Orthopedics, Inc.K231526CORAIL Cemented Femoral StemDepuy Ireland UC K223441SpaceFlex 髋臼杯G21, S.R.L.K221794Vario-Cup 系統Waldemar Link GmbH & Co. KG K220492COPAL交換G 髋間隔離器Heraeus Medical GmbH

官方來源

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