FDA 510(k)

CarboClear® II 頸椎螺釘系統

K 號：K200519 · 2020-04-30

決定日期2020-04-30

產品代碼NKB

諮詢委員會或

決定相當於

器材摘要

CarboClear® II Pedicle Screw System is the device name listed in this FDA 510(k) record. The listed applicant is CarboFix Orthopedics , Ltd.. It received FDA 510(k) clearance on 2020-04-30 under 510(k) number K200519. 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 CarboClear® II Pedicle Screw System?

CarboClear® II Pedicle Screw System is a medical device that received FDA 510(k) clearance on 2020-04-30. The listed applicant is CarboFix Orthopedics , Ltd.. The 510(k) number is K200519.

When did CarboClear® II Pedicle Screw System receive FDA 510(k) clearance?

CarboClear® II Pedicle Screw System received FDA 510(k) clearance on 2020-04-30, under 510(k) number K200519.

Who is the listed applicant for CarboClear® II Pedicle Screw System?

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

What is the FDA product code for CarboClear® II Pedicle Screw System?

The FDA product code for CarboClear® II Pedicle Screw System is NKB.

其他以 CarboFix Orthopedics , 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。

K254045CarboClear® 頸椎後路螺釘系統；CarboClear® 混合後路螺釘系統 K243106CarboClear®雙柱體螺釘系統 K233793CarboClear® X 頸椎螺釘系統 K240846CarboClear®雙模組椎板釘系統；CarboClear®雙模組導航工具；CarboClear®雙模組窗孔椎板釘系統及High V+®骨水泥；CarboClear®X窗孔椎板釘系統及High V+®骨水泥 K233989CarboClear® 頸椎後路螺釘系統 K233944CarboClear® X 頸椎螺釘系統；CarboClear® X 經導儀器

查看所有 25 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。