FDA 510(k)

上海三友CARMEN脊椎融合系統

K 號：K163366 · 2017-10-05

決定日期2017-10-05

產品代碼KWQ

諮詢委員會或

決定相當於

器材摘要

Shanghai Sanyou CARMEN Cervical Fusion System is the device name listed in this FDA 510(k) record. The listed applicant is Shanghai Sanyou Medical Co, Ltd.. It received FDA 510(k) clearance on 2017-10-05 under 510(k) number K163366. The device is classified under product code KWQ. It was reviewed by the OR advisory panel. FDA Decision: Substantially Equivalent.

常見問題

What is the Shanghai Sanyou CARMEN Cervical Fusion System?

Shanghai Sanyou CARMEN Cervical Fusion System is a medical device that received FDA 510(k) clearance on 2017-10-05. The listed applicant is Shanghai Sanyou Medical Co, Ltd.. The 510(k) number is K163366.

When did Shanghai Sanyou CARMEN Cervical Fusion System receive FDA 510(k) clearance?

Shanghai Sanyou CARMEN Cervical Fusion System received FDA 510(k) clearance on 2017-10-05, under 510(k) number K163366.

Who is the listed applicant for Shanghai Sanyou CARMEN Cervical Fusion System?

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

What is the FDA product code for Shanghai Sanyou CARMEN Cervical Fusion System?

The FDA product code for Shanghai Sanyou CARMEN Cervical Fusion System is KWQ.

其他以 Shanghai Sanyou Medical Co, Ltd. 為申請人之記錄

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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相關器械（代碼：KWQ）

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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