FDA 510(k)

Optetrak One Logic 髋關節組件

K 號：K153776 · 2016-03-10

決定日期2016-03-10

產品代碼MBH

諮詢委員會或

決定相當於

器材摘要

Optetrak One Logic Femoral Components is the device name listed in this FDA 510(k) record. The listed applicant is Exactech, Inc.. It received FDA 510(k) clearance on 2016-03-10 under 510(k) number K153776. The device is classified under product code MBH. It was reviewed by the OR advisory panel. FDA Decision: Substantially Equivalent.

常見問題

What is the Optetrak One Logic Femoral Components?

Optetrak One Logic Femoral Components is a medical device that received FDA 510(k) clearance on 2016-03-10. The listed applicant is Exactech, Inc.. The 510(k) number is K153776.

When did Optetrak One Logic Femoral Components receive FDA 510(k) clearance?

Optetrak One Logic Femoral Components received FDA 510(k) clearance on 2016-03-10, under 510(k) number K153776.

Who is the listed applicant for Optetrak One Logic Femoral Components?

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

What is the FDA product code for Optetrak One Logic Femoral Components?

The FDA product code for Optetrak One Logic Femoral Components is MBH.

其他以 Exactech, Inc. 為申請人之記錄

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相關器械（代碼：MBH）

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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