FDA 510(k)

CD Horizon™脊椎系統

K 號：K221244 · 2022-05-25

決定日期2022-05-25

產品代碼NKB

諮詢委員會或

決定相當於

器材摘要

CD Horizon™ Spinal System is the device name listed in this FDA 510(k) record. The listed applicant is Medtronic. It received FDA 510(k) clearance on 2022-05-25 under 510(k) number K221244. 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 CD Horizon™ Spinal System?

CD Horizon™ Spinal System is a medical device that received FDA 510(k) clearance on 2022-05-25. The listed applicant is Medtronic. The 510(k) number is K221244.

When did CD Horizon™ Spinal System receive FDA 510(k) clearance?

CD Horizon™ Spinal System received FDA 510(k) clearance on 2022-05-25, under 510(k) number K221244.

Who is the listed applicant for CD Horizon™ Spinal System?

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

What is the FDA product code for CD Horizon™ Spinal System?

The FDA product code for CD Horizon™ Spinal System is NKB.

其他以 Medtronic 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。

K253530Trexon™ 单絲合成可吸收縫線 K251744Affinity Pixie™ 動脈濾器配平衡™ 生物表面；Affinity® 優幼兒動脈血濾器 K233433球體-9Dx 診斷導管 (AFR-00009)K240190MYOtherm XP 心肌停搏液輸送系統搭配 Cortiva 生物活性表面，MYOtherm XP 心肌停搏液輸送系統未包裝 K223494CD Horizon脊椎系統 K223178SelectSite C304 可調向導管系統，C315 導管輸送系統

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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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