FDA 510(k)

KHEIRON®脊椎固定系統

K 號：K201659 · 2020-10-05

申請人S.M.A.I.O

決定日期2020-10-05

產品代碼NKB

諮詢委員會或

決定相當於

器材摘要

KHEIRON® Spinal Fixation System is the device name listed in this FDA 510(k) record. The listed applicant is S.M.A.I.O. It received FDA 510(k) clearance on 2020-10-05 under 510(k) number K201659. 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 KHEIRON® Spinal Fixation System?

KHEIRON® Spinal Fixation System is a medical device that received FDA 510(k) clearance on 2020-10-05. The listed applicant is S.M.A.I.O. The 510(k) number is K201659.

When did KHEIRON® Spinal Fixation System receive FDA 510(k) clearance?

KHEIRON® Spinal Fixation System received FDA 510(k) clearance on 2020-10-05, under 510(k) number K201659.

Who is the listed applicant for KHEIRON® Spinal Fixation System?

FDA 510(k) 記錄將 S.M.A.I.O 列為申請人。這並不單獨確立設備製造商。

What is the FDA product code for KHEIRON® Spinal Fixation System?

The FDA product code for KHEIRON® Spinal Fixation System is NKB.

其他以 S.M.A.I.O 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。

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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

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