FDA 510(k)

b-ONE®雙極頭

K 號：K253357 · 2026-04-13

決定日期2026-04-13

產品代碼KWY

諮詢委員會或

決定相當於

器材摘要

b-ONE® Bipolar Head is the device name listed in this FDA 510(k) record. The listed applicant is B-One Ortho, Corp.. It received FDA 510(k) clearance on 2026-04-13 under 510(k) number K253357. 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 b-ONE® Bipolar Head?

b-ONE® Bipolar Head is a medical device that received FDA 510(k) clearance on 2026-04-13. The listed applicant is B-One Ortho, Corp.. The 510(k) number is K253357.

When did b-ONE® Bipolar Head receive FDA 510(k) clearance?

b-ONE® Bipolar Head received FDA 510(k) clearance on 2026-04-13, under 510(k) number K253357.

Who is the listed applicant for b-ONE® Bipolar Head?

FDA 510(k) 記錄將 B-One Ortho, Corp. 列為申請人。這並不單獨確立設備製造商。

What is the FDA product code for b-ONE® Bipolar Head?

The FDA product code for b-ONE® Bipolar Head is KWY.

其他以 B-One Ortho, Corp. 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。

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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。

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 K200709京瓷雙極股骨系統Kyocera Medical Technologies, Inc.

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。