FDA 510(k)

A.M. 外科髓內固定設備

K 號：K180087 · 2018-05-18

決定日期2018-05-18

產品代碼HTY

諮詢委員會或

決定相當於

器材摘要

A.M. Surgical Intramedullary Fixation Device is the device name listed in this FDA 510(k) record. The listed applicant is A.M. Surgical, Inc.. It received FDA 510(k) clearance on 2018-05-18 under 510(k) number K180087. The device is classified under product code HTY. It was reviewed by the OR advisory panel. FDA Decision: Substantially Equivalent.

常見問題

What is the A.M. Surgical Intramedullary Fixation Device?

A.M. Surgical Intramedullary Fixation Device is a medical device that received FDA 510(k) clearance on 2018-05-18. The listed applicant is A.M. Surgical, Inc.. The 510(k) number is K180087.

When did A.M. Surgical Intramedullary Fixation Device receive FDA 510(k) clearance?

A.M. Surgical Intramedullary Fixation Device received FDA 510(k) clearance on 2018-05-18, under 510(k) number K180087.

Who is the listed applicant for A.M. Surgical Intramedullary Fixation Device?

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

What is the FDA product code for A.M. Surgical Intramedullary Fixation Device?

The FDA product code for A.M. Surgical Intramedullary Fixation Device is HTY.

其他以 A.M. Surgical, Inc. 為申請人之記錄

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相關器械（代碼：HTY）

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