FDA 510(k)

CapLOX II®/TowerLOX® 微創椎板釘系統

K 號：K193270 · 2020-01-31

決定日期2020-01-31

產品代碼NKB

諮詢委員會或

決定相當於

器材摘要

CapLOX II®/TowerLOX® MIS Pedicle Screw System is the device name listed in this FDA 510(k) record. The listed applicant is Captiva Spine, Inc.. It received FDA 510(k) clearance on 2020-01-31 under 510(k) number K193270. 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 CapLOX II®/TowerLOX® MIS Pedicle Screw System?

CapLOX II®/TowerLOX® MIS Pedicle Screw System is a medical device that received FDA 510(k) clearance on 2020-01-31. The listed applicant is Captiva Spine, Inc.. The 510(k) number is K193270.

When did CapLOX II®/TowerLOX® MIS Pedicle Screw System receive FDA 510(k) clearance?

CapLOX II®/TowerLOX® MIS Pedicle Screw System received FDA 510(k) clearance on 2020-01-31, under 510(k) number K193270.

Who is the listed applicant for CapLOX II®/TowerLOX® MIS Pedicle Screw System?

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

What is the FDA product code for CapLOX II®/TowerLOX® MIS Pedicle Screw System?

The FDA product code for CapLOX II®/TowerLOX® MIS Pedicle Screw System is NKB.

其他以 Captiva Spine, Inc. 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。

K181229TirboLOX-C 頸部 IBFD K180990TirboLOX-L 腰椎 IBFD K180475CapLOX II® / TowerLOX® MIS脊椎釘系統

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

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