FDA 510(k)

InterForm 頸椎間置架系統

K 號：K161608 · 2016-09-30

決定日期2016-09-30

產品代碼ODP

諮詢委員會或

決定相當於

器材摘要

InterForm Cervical Interbody Cage System is the device name listed in this FDA 510(k) record. The listed applicant is Next Orthosurgical. It received FDA 510(k) clearance on 2016-09-30 under 510(k) number K161608. 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 InterForm Cervical Interbody Cage System?

InterForm Cervical Interbody Cage System is a medical device that received FDA 510(k) clearance on 2016-09-30. The listed applicant is Next Orthosurgical. The 510(k) number is K161608.

When did InterForm Cervical Interbody Cage System receive FDA 510(k) clearance?

InterForm Cervical Interbody Cage System received FDA 510(k) clearance on 2016-09-30, under 510(k) number K161608.

Who is the listed applicant for InterForm Cervical Interbody Cage System?

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

What is the FDA product code for InterForm Cervical Interbody Cage System?

The FDA product code for InterForm Cervical Interbody Cage System is ODP.

其他以 Next Orthosurgical 為申請人之記錄

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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。

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