FDA 510(k)

MySpine脊椎椎板螺釘置入導引器 – MC及钻頭導引工具

K 號：K173472 · 2018-04-19

決定日期2018-04-19

產品代碼PQC

諮詢委員會或

決定相當於

器材摘要

MySpine Pedicle Screw Placement Guides – MC and Drill Pilot Instruments is the device name listed in this FDA 510(k) record. The listed applicant is Medacta International S.A.. It received FDA 510(k) clearance on 2018-04-19 under 510(k) number K173472. The device is classified under product code PQC. It was reviewed by the OR advisory panel. FDA Decision: Substantially Equivalent.

常見問題

What is the MySpine Pedicle Screw Placement Guides – MC and Drill Pilot Instruments?

MySpine Pedicle Screw Placement Guides – MC and Drill Pilot Instruments is a medical device that received FDA 510(k) clearance on 2018-04-19. The listed applicant is Medacta International S.A.. The 510(k) number is K173472.

When did MySpine Pedicle Screw Placement Guides – MC and Drill Pilot Instruments receive FDA 510(k) clearance?

MySpine Pedicle Screw Placement Guides – MC and Drill Pilot Instruments received FDA 510(k) clearance on 2018-04-19, under 510(k) number K173472.

Who is the listed applicant for MySpine Pedicle Screw Placement Guides – MC and Drill Pilot Instruments?

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

What is the FDA product code for MySpine Pedicle Screw Placement Guides – MC and Drill Pilot Instruments?

The FDA product code for MySpine Pedicle Screw Placement Guides – MC and Drill Pilot Instruments is PQC.

其他以 Medacta International S.A. 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：PQC）

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。

K253472FIREFLY®脊椎釘導航指南Mighty Oak Medical K231483MySpine 雙邊導引器Medacta International S.A.K203673MySpine 頸椎螺釘置入導引器擴充套件（MySpine 低輪廓導引器、MySpine MC 和鑽孔導引器、以及 MySpine S2-Alar/Alar Iliac 導引器）Medacta International S.A.K200792MySpine S2-側翼/側翼-坐骨棘螺釘置入導引器Medacta Inernational SA K181883FIREFLY® 中線導航指南Mighty Oak Medical, Inc.K181399FIREFLY®脊椎釘導航指南Mighty Oak Medical, Inc.

官方來源

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