FDA 510(k)

Adena-Zina Spinal System

K 號：K231931 · 2023-07-28

決定日期2023-07-28

產品代碼NKB

諮詢委員會或

決定相當於

器材摘要

Adena-Zina Spinal 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 2023-07-28 under 510(k) number K231931. The device is classified under product code NKB. It was reviewed by the OR advisory panel. FDA Decision: Substantially Equivalent.

常見問題

What is the Adena-Zina Spinal System?

Adena-Zina Spinal System is a medical device that received FDA 510(k) clearance on 2023-07-28. The listed applicant is Shanghai Sanyou Medical Co, Ltd.. The 510(k) number is K231931.

When did Adena-Zina Spinal System receive FDA 510(k) clearance?

Adena-Zina Spinal System received FDA 510(k) clearance on 2023-07-28, under 510(k) number K231931.

Who is the listed applicant for Adena-Zina Spinal 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 Adena-Zina Spinal System?

The FDA product code for Adena-Zina Spinal System is NKB.

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。

K230872Halis™ 腰椎金層系統，Lydia™ 前腰椎融合系統，Dica™ 方向可變腰椎金層系統，KEYSTONE 金層系統 K230961宙斯脊椎系統 K211689基石PEEK籠架系統 K212066Adena-Zina System K163366上海三友CARMEN脊椎融合系統 K163422上海三友PEEK籠架系統

查看所有 8 項裝置 →

相關器械（代碼：NKB）

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。

K252139肯特羅斯賓 Viktr-MIS® 椎板螺釘系統Rivarp Medical Pvt., Ltd.K262067iFuse Granite Onyx™ 假骨植入系統SI-BONE, Inc.K262091FRAXION脊椎固定系統Ortler Global Tibbi Gerecler Anonim Sirketi K262193RIVA® 後固定系統搭配NanoACTIV表面技術；RIVA® 髋骨結合固定釘搭配NanoACTIV表面技術Xenix Medical K262828KHEIRON®脊椎固定系統，包括客製化K-RODS.M.A.I.O K260362QUATTRO脊椎系統（開放配置）；QUATTRO-GADGET脊椎系統（MIS配置）MANTIZ Co., Ltd.

官方來源

在 FDA 資料庫中查看 →

資料來源為 FDA Open API。如需最新且權威的資訊，請始終參閱官方記錄。