FIREFLY®脊椎釘導航指南
K 號：K253472 · 2026-02-25
廣告
器材摘要
FIREFLY® Pedicle Screw Navigation Guide is the device name listed in this FDA 510(k) record. The listed applicant is Mighty Oak Medical. It received FDA 510(k) clearance on 2026-02-25 under 510(k) number K253472. 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 FIREFLY® Pedicle Screw Navigation Guide?
FIREFLY® Pedicle Screw Navigation Guide is a medical device that received FDA 510(k) clearance on 2026-02-25. The listed applicant is Mighty Oak Medical. The 510(k) number is K253472.
When did FIREFLY® Pedicle Screw Navigation Guide receive FDA 510(k) clearance?
FIREFLY® Pedicle Screw Navigation Guide received FDA 510(k) clearance on 2026-02-25, under 510(k) number K253472.
Who is the listed applicant for FIREFLY® Pedicle Screw Navigation Guide?
The FDA 510(k) record lists Mighty Oak Medical as the applicant. This does not by itself establish the device manufacturer.
What is the FDA product code for FIREFLY® Pedicle Screw Navigation Guide?
The FDA product code for FIREFLY® Pedicle Screw Navigation Guide is PQC.
相關臨床試驗
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。
其他以 Mighty Oak Medical 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。
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。
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 SAK181883FIREFLY® 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
在 FDA 資料庫中查看 →資料來源為 FDA Open API。如需最新且權威的資訊，請始終參閱官方記錄。
廣告