FDA 510(k)

英格尼克斯脊椎系統

K 號：K241258 · 2024-06-04

決定日期2024-06-04

產品代碼NKB

諮詢委員會或

決定相當於

器材摘要

Ingenix Spinal System is the device name listed in this FDA 510(k) record. The listed applicant is Ingenium Spine. It received FDA 510(k) clearance on 2024-06-04 under 510(k) number K241258. 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 Ingenix Spinal System?

Ingenix Spinal System is a medical device that received FDA 510(k) clearance on 2024-06-04. The listed applicant is Ingenium Spine. The 510(k) number is K241258.

When did Ingenix Spinal System receive FDA 510(k) clearance?

Ingenix Spinal System received FDA 510(k) clearance on 2024-06-04, under 510(k) number K241258.

Who is the listed applicant for Ingenix Spinal System?

The FDA 510(k) record lists Ingenium Spine as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Ingenix Spinal System?

The FDA product code for Ingenix Spinal System is NKB.

其他以 Ingenium Spine 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。

K173126Arisstos™ 骨盆系統

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。