FDA 510(k)

K2M可擴展椎間體系統

K 號：K180777 · 2018-08-03

決定日期2018-08-03

產品代碼MAX

諮詢委員會或

決定相當於

器材摘要

K2M Expandable Interbody System is the device name listed in this FDA 510(k) record. The listed applicant is K2m, Inc.. It received FDA 510(k) clearance on 2018-08-03 under 510(k) number K180777. The device is classified under product code MAX. It was reviewed by the OR advisory panel. FDA Decision: Substantially Equivalent.

常見問題

What is the K2M Expandable Interbody System?

K2M Expandable Interbody System is a medical device that received FDA 510(k) clearance on 2018-08-03. The listed applicant is K2m, Inc.. The 510(k) number is K180777.

When did K2M Expandable Interbody System receive FDA 510(k) clearance?

K2M Expandable Interbody System received FDA 510(k) clearance on 2018-08-03, under 510(k) number K180777.

Who is the listed applicant for K2M Expandable Interbody System?

The FDA 510(k) record lists K2m, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for K2M Expandable Interbody System?

The FDA product code for K2M Expandable Interbody System is MAX.

其他以 K2m, Inc. 為申請人之記錄

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相關器械（代碼：MAX）

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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