FDA 510(k)

Optetrak邏輯骨幹锥

K 號：K153595 · 2016-03-25

決定日期2016-03-25

產品代碼JWH

諮詢委員會或

決定相當於

器材摘要

Optetrak Logic Metaphyseal Cones is the device name listed in this FDA 510(k) record. The listed applicant is Exactech, Inc.. It received FDA 510(k) clearance on 2016-03-25 under 510(k) number K153595. The device is classified under product code JWH. It was reviewed by the OR advisory panel. FDA Decision: Substantially Equivalent.

常見問題

What is the Optetrak Logic Metaphyseal Cones?

Optetrak Logic Metaphyseal Cones is a medical device that received FDA 510(k) clearance on 2016-03-25. The listed applicant is Exactech, Inc.. The 510(k) number is K153595.

When did Optetrak Logic Metaphyseal Cones receive FDA 510(k) clearance?

Optetrak Logic Metaphyseal Cones received FDA 510(k) clearance on 2016-03-25, under 510(k) number K153595.

Who is the listed applicant for Optetrak Logic Metaphyseal Cones?

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 Logic Metaphyseal Cones?

The FDA product code for Optetrak Logic Metaphyseal Cones is JWH.

其他以 Exactech, Inc. 為申請人之記錄

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相關器械（代碼：JWH）

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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