FDA 510(k)

KHEIRON脊椎固定系統

K 號：K211414 · 2021-08-10

申請人S.M.A.I.O

決定日期2021-08-10

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 2021-08-10 under 510(k) number K211414. 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 2021-08-10. The listed applicant is S.M.A.I.O. The 510(k) number is K211414.

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

KHEIRON Spinal Fixation System received FDA 510(k) clearance on 2021-08-10, under 510(k) number K211414.

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。

K262828KHEIRON®脊椎固定系統，包括客製化K-ROD K261500KBA3D (v2.4.0)K253802KHEIRON®脊椎固定系統，包括客製化K-ROD K260786KHEIRON®脊椎固定系統，包括客製化K-ROD K253990KHEIRON®脊椎固定系統，包括客製化K-ROD K253721KHEIRON®脊椎固定系統，包括客製化K-ROD

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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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