FDA 510(k)

Orthex 外固定系統

K 號：K243798 · 2025-03-07

決定日期2025-03-07

產品代碼KTT

諮詢委員會或

決定相當於

器材摘要

Orthex External Fixation System is the device name listed in this FDA 510(k) record. The listed applicant is OrthoPediatrics Corp.. It received FDA 510(k) clearance on 2025-03-07 under 510(k) number K243798. The device is classified under product code KTT. It was reviewed by the OR advisory panel. FDA Decision: Substantially Equivalent.

常見問題

What is the Orthex External Fixation System?

Orthex External Fixation System is a medical device that received FDA 510(k) clearance on 2025-03-07. The listed applicant is OrthoPediatrics Corp.. The 510(k) number is K243798.

When did Orthex External Fixation System receive FDA 510(k) clearance?

Orthex External Fixation System received FDA 510(k) clearance on 2025-03-07, under 510(k) number K243798.

Who is the listed applicant for Orthex External Fixation System?

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

What is the FDA product code for Orthex External Fixation System?

The FDA product code for Orthex External Fixation System is KTT.

其他以 OrthoPediatrics Corp. 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。

K261345兒童釘針平台髋骨 K260323OrthoPediatrics® 鎖定中空刀片板系統 K252600兒童植板平台 I 小型-迷你 K251362PediFlex™ 強韌指甲系統 K243963兒童植板平台髋 K250623兒童釘針平台道骨兒童釘針平台股骨

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相關器械（代碼：KTT）

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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