FDA 510(k)

OMNI Anseris 髋關節頭

K 號：K171156 · 2017-08-17

決定日期2017-08-17

產品代碼LZO

諮詢委員會或

決定相當於

器材摘要

OMNI Anseris Hip Stem is the device name listed in this FDA 510(k) record. The listed applicant is Omnilife Science. It received FDA 510(k) clearance on 2017-08-17 under 510(k) number K171156. 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 OMNI Anseris Hip Stem?

OMNI Anseris Hip Stem is a medical device that received FDA 510(k) clearance on 2017-08-17. The listed applicant is Omnilife Science. The 510(k) number is K171156.

When did OMNI Anseris Hip Stem receive FDA 510(k) clearance?

OMNI Anseris Hip Stem received FDA 510(k) clearance on 2017-08-17, under 510(k) number K171156.

Who is the listed applicant for OMNI Anseris Hip Stem?

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

What is the FDA product code for OMNI Anseris Hip Stem?

The FDA product code for OMNI Anseris Hip Stem is LZO.

其他以 Omnilife Science 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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