FDA 510(k)

ENNOVATE®

K 號：K180433 · 2018-04-26

決定日期2018-04-26

產品代碼NKB

諮詢委員會或

決定相當於

器材摘要

ENNOVATE® is the device name listed in this FDA 510(k) record. The listed applicant is Aesculap Implant Systems, LLC. It received FDA 510(k) clearance on 2018-04-26 under 510(k) number K180433. 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 ENNOVATE®?

ENNOVATE® is a medical device that received FDA 510(k) clearance on 2018-04-26. The listed applicant is Aesculap Implant Systems, LLC. The 510(k) number is K180433.

When did ENNOVATE® receive FDA 510(k) clearance?

ENNOVATE® received FDA 510(k) clearance on 2018-04-26, under 510(k) number K180433.

Who is the listed applicant for ENNOVATE®?

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

What is the FDA product code for ENNOVATE®?

The FDA product code for ENNOVATE® is NKB.

其他以 Aesculap Implant Systems, 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。

K213871Ennovate脊椎頸部及枕骨系統 K210963ENNOVATE脊椎系統 K162134ENNOVATE脊椎系統 K153700Aesculap(R) 假體系統 (AIS) S4 導航器具 K153396Aesculap OrthoPilot 新一代

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。