FDA 510(k)

G外科精準手術系統

K 號：K161516 · 2016-08-25

決定日期2016-08-25

產品代碼NKB

諮詢委員會或

決定相當於

器材摘要

G Surgical Marksman MIS System is the device name listed in this FDA 510(k) record. The listed applicant is G Surgical, LLC. It received FDA 510(k) clearance on 2016-08-25 under 510(k) number K161516. 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 G Surgical Marksman MIS System?

G Surgical Marksman MIS System is a medical device that received FDA 510(k) clearance on 2016-08-25. The listed applicant is G Surgical, LLC. The 510(k) number is K161516.

When did G Surgical Marksman MIS System receive FDA 510(k) clearance?

G Surgical Marksman MIS System received FDA 510(k) clearance on 2016-08-25, under 510(k) number K161516.

Who is the listed applicant for G Surgical Marksman MIS System?

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

What is the FDA product code for G Surgical Marksman MIS System?

The FDA product code for G Surgical Marksman MIS System is NKB.

其他以 G Surgical, LLC 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。

K240737G外科精準手術系統 K230063G外科精準手術脊椎變形系統 K210890GPS頸椎間隔器 K193219G外科標誌系統 K171834G外科脊椎系統光學斷層掃描儀

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。