FDA 510(k)

ANCHORMAN 靴骨韌帶固定器

K 號：K170388 · 2017-07-25

決定日期2017-07-25

產品代碼MBI

諮詢委員會或

決定相當於

器材摘要

ANCHORMAN Tibial Ligament Fixation Device is the device name listed in this FDA 510(k) record. The listed applicant is Summit Medical , Ltd.. It received FDA 510(k) clearance on 2017-07-25 under 510(k) number K170388. The device is classified under product code MBI. It was reviewed by the OR advisory panel. FDA Decision: Substantially Equivalent.

常見問題

What is the ANCHORMAN Tibial Ligament Fixation Device?

ANCHORMAN Tibial Ligament Fixation Device is a medical device that received FDA 510(k) clearance on 2017-07-25. The listed applicant is Summit Medical , Ltd.. The 510(k) number is K170388.

When did ANCHORMAN Tibial Ligament Fixation Device receive FDA 510(k) clearance?

ANCHORMAN Tibial Ligament Fixation Device received FDA 510(k) clearance on 2017-07-25, under 510(k) number K170388.

Who is the listed applicant for ANCHORMAN Tibial Ligament Fixation Device?

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

What is the FDA product code for ANCHORMAN Tibial Ligament Fixation Device?

The FDA product code for ANCHORMAN Tibial Ligament Fixation Device is MBI.

其他以 Summit Medical , Ltd. 為申請人之記錄

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K173110植床地

相關器械（代碼：MBI）

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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