Adaptix Ortho350
K 號：K252133 · 2025-11-06
廣告
器材摘要
Adaptix Ortho350 is the device name listed in this FDA 510(k) record. The listed applicant is Adaptix Limited. It received FDA 510(k) clearance on 2025-11-06 under 510(k) number K252133. The device is classified under product code IZF. It was reviewed by the RA advisory panel. FDA Decision: Substantially Equivalent.
常見問題
What is the Adaptix Ortho350?
Adaptix Ortho350 is a medical device that received FDA 510(k) clearance on 2025-11-06. The listed applicant is Adaptix Limited. The 510(k) number is K252133.
When did Adaptix Ortho350 receive FDA 510(k) clearance?
Adaptix Ortho350 received FDA 510(k) clearance on 2025-11-06, under 510(k) number K252133.
Who is the listed applicant for Adaptix Ortho350?
The FDA 510(k) record lists Adaptix Limited as the applicant. This does not by itself establish the device manufacturer.
What is the FDA product code for Adaptix Ortho350?
The FDA product code for Adaptix Ortho350 is IZF.
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。
相關器械（代碼：IZF）
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。
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