FDA 510(k)

b-ONE® 全髋關節系統

K 號：K173380 · 2018-08-30

決定日期2018-08-30

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 2018-08-30 under 510(k) number K173380. 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 2018-08-30. The listed applicant is B-One Ortho, Corp.. The 510(k) number is K173380.

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

b-ONE® Total Hip System received FDA 510(k) clearance on 2018-08-30, under 510(k) number K173380.

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。

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官方來源

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