FDA 510(k)

雙重活動度系統 BI-MENTUM

K 號：K181744 · 2018-12-11

申請人Serf

決定日期2018-12-11

產品代碼LZO

諮詢委員會或

決定相當於

器材摘要

BI-MENTUM dual mobility system is the device name listed in this FDA 510(k) record. The listed applicant is Serf. It received FDA 510(k) clearance on 2018-12-11 under 510(k) number K181744. 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 BI-MENTUM dual mobility system?

BI-MENTUM dual mobility system is a medical device that received FDA 510(k) clearance on 2018-12-11. The listed applicant is Serf. The 510(k) number is K181744.

When did BI-MENTUM dual mobility system receive FDA 510(k) clearance?

BI-MENTUM dual mobility system received FDA 510(k) clearance on 2018-12-11, under 510(k) number K181744.

Who is the listed applicant for BI-MENTUM dual mobility system?

The FDA 510(k) record lists Serf as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for BI-MENTUM dual mobility system?

The FDA product code for BI-MENTUM dual mobility system is LZO.

其他以 Serf 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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