FDA 510(k)

SUSTAIN 適用式植入體

K 號：K151665 · 2016-03-16

決定日期2016-03-16

產品代碼MAX

諮詢委員會或

決定相當於

器材摘要

SUSTAIN Additional Implants is the device name listed in this FDA 510(k) record. The listed applicant is Globus Medical, Inc.. It received FDA 510(k) clearance on 2016-03-16 under 510(k) number K151665. 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 SUSTAIN Additional Implants?

SUSTAIN Additional Implants is a medical device that received FDA 510(k) clearance on 2016-03-16. The listed applicant is Globus Medical, Inc.. The 510(k) number is K151665.

When did SUSTAIN Additional Implants receive FDA 510(k) clearance?

SUSTAIN Additional Implants received FDA 510(k) clearance on 2016-03-16, under 510(k) number K151665.

Who is the listed applicant for SUSTAIN Additional Implants?

FDA 510(k) 記錄將 Globus Medical, Inc. 列為申請人。這並不單獨確立設備製造商。

What is the FDA product code for SUSTAIN Additional Implants?

The FDA product code for SUSTAIN Additional Implants is MAX.

其他以 Globus Medical, 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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