FDA 510(k)

b-ONE® 全髋關節系統

K 號：K240528 · 2024-11-15

決定日期2024-11-15

產品代碼LZO

諮詢委員會或

決定相當於

器材摘要

b-ONE® Total Hip System 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 2024-11-15 under 510(k) number K240528. The device is classified under product code LZO. It was reviewed by the OR advisory panel. FDA Decision: Substantially Equivalent.

常見問題

What is the b-ONE® Total Hip System?

b-ONE® Total Hip System is a medical device that received FDA 510(k) clearance on 2024-11-15. The listed applicant is B-One Ortho, Corp.. The 510(k) number is K240528.

When did b-ONE® Total Hip System receive FDA 510(k) clearance?

b-ONE® Total Hip System received FDA 510(k) clearance on 2024-11-15, under 510(k) number K240528.

Who is the listed applicant for b-ONE® Total Hip System?

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® Total Hip System?

The FDA product code for b-ONE® Total Hip System is LZO.

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：LZO）

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。

K260173M-Vizion 髋關節更換系統擴充版Medacta International S.A.K253948動力骨盂杯系統United Orthopedic Corporation K261009MobileLink 骨盆杯系統 – 40mm ID 插片（各種）Waldemar Link GmbH & Co. KG K260831Z1 髋關節系統Zimmer, Inc.K260182Avenir® Müller 植入物；Avenir Complete™ 髋關節系統Zimmer, Inc.K260037植入式醫療設備包裝系統更新Implantcast GmbH

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。