RI.KNEE 調節式胫骨切線導引器
K 號：K230876 · 2023-06-27
廣告
器材摘要
RI.KNEE Adjustable Tibia Cut Guide is the device name listed in this FDA 510(k) record. The listed applicant is Enztec Limited. It received FDA 510(k) clearance on 2023-06-27 under 510(k) number K230876. The device is classified under product code OLO. It was reviewed by the NE advisory panel. FDA Decision: Substantially Equivalent.
常見問題
What is the RI.KNEE Adjustable Tibia Cut Guide?
RI.KNEE Adjustable Tibia Cut Guide is a medical device that received FDA 510(k) clearance on 2023-06-27. The listed applicant is Enztec Limited. The 510(k) number is K230876.
When did RI.KNEE Adjustable Tibia Cut Guide receive FDA 510(k) clearance?
RI.KNEE Adjustable Tibia Cut Guide received FDA 510(k) clearance on 2023-06-27, under 510(k) number K230876.
Who is the listed applicant for RI.KNEE Adjustable Tibia Cut Guide?
The FDA 510(k) record lists Enztec Limited as the applicant. This does not by itself establish the device manufacturer.
What is the FDA product code for RI.KNEE Adjustable Tibia Cut Guide?
The FDA product code for RI.KNEE Adjustable Tibia Cut Guide is OLO.
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 Enztec Limited 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：OLO）
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