FDA 510(k)

MySpine 雙邊導引器

K 號：K231483 · 2023-07-21

決定日期2023-07-21

產品代碼PQC

諮詢委員會或

決定相當於

器材摘要

MySpine Unilateral Guides 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 2023-07-21 under 510(k) number K231483. 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 Unilateral Guides?

MySpine Unilateral Guides is a medical device that received FDA 510(k) clearance on 2023-07-21. The listed applicant is Medacta International S.A.. The 510(k) number is K231483.

When did MySpine Unilateral Guides receive FDA 510(k) clearance?

MySpine Unilateral Guides received FDA 510(k) clearance on 2023-07-21, under 510(k) number K231483.

Who is the listed applicant for MySpine Unilateral Guides?

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 Unilateral Guides?

The FDA product code for MySpine Unilateral Guides 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 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.K173472MySpine脊椎椎板螺釘置入導引器 – MC及钻頭導引工具Medacta International S.A.

官方來源

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