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FDA 510(k)

IMSE 頸椎籠架

K 號:K162003 · 2016-12-21

決定日期2016-12-21
產品代碼ODP
諮詢委員會或
決定相當於

器材摘要

IMSE Cervical Cage is the device name listed in this FDA 510(k) record. The listed applicant is The Institute of Musculoskeletal Science & Education. It received FDA 510(k) clearance on 2016-12-21 under 510(k) number K162003. The device is classified under product code ODP. It was reviewed by the OR advisory panel. FDA Decision: Substantially Equivalent.

常見問題

What is the IMSE Cervical Cage?

IMSE Cervical Cage is a medical device that received FDA 510(k) clearance on 2016-12-21. The listed applicant is The Institute of Musculoskeletal Science & Education. The 510(k) number is K162003.

When did IMSE Cervical Cage receive FDA 510(k) clearance?

IMSE Cervical Cage received FDA 510(k) clearance on 2016-12-21, under 510(k) number K162003.

Who is the listed applicant for IMSE Cervical Cage?

The FDA 510(k) record lists The Institute of Musculoskeletal Science & Education as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for IMSE Cervical Cage?

The FDA product code for IMSE Cervical Cage is ODP.

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相關器械(代碼:ODP)

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。

官方來源

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