FDA 510(k)

Altus Spine 椎弓釘系統

K 號：K200322 · 2020-06-02

決定日期2020-06-02

產品代碼NKB

諮詢委員會或

決定相當於

器材摘要

Altus Spine Pedicle Screw System is the device name listed in this FDA 510(k) record. The listed applicant is Altus Partners, LLC. It received FDA 510(k) clearance on 2020-06-02 under 510(k) number K200322. 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 Altus Spine Pedicle Screw System?

Altus Spine Pedicle Screw System is a medical device that received FDA 510(k) clearance on 2020-06-02. The listed applicant is Altus Partners, LLC. The 510(k) number is K200322.

When did Altus Spine Pedicle Screw System receive FDA 510(k) clearance?

Altus Spine Pedicle Screw System received FDA 510(k) clearance on 2020-06-02, under 510(k) number K200322.

Who is the listed applicant for Altus Spine Pedicle Screw System?

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

What is the FDA product code for Altus Spine Pedicle Screw System?

The FDA product code for Altus Spine Pedicle Screw System is NKB.

其他以 Altus Partners, 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。

K243419Altus Spine 導航系統 K211027Altus Spine 椎弓釘系統 K211837Altus Spine 間融合獨立系統 K210887Altus Spine Sochi OCT 腰椎系統 K200922Altus Spine HA 椎弓釘系統 K183084富士脊椎板系統

查看所有 16 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。