DigiFix 無菌套件
K 號：K192465 · 2019-10-10
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器材摘要
DigiFix Sterile Kit is the device name listed in this FDA 510(k) record. The listed applicant is Virak Orthopedics, LLC. It received FDA 510(k) clearance on 2019-10-10 under 510(k) number K192465. The device is classified under product code JEC. It was reviewed by the OR advisory panel. FDA Decision: Substantially Equivalent.
常見問題
What is the DigiFix Sterile Kit?
DigiFix Sterile Kit is a medical device that received FDA 510(k) clearance on 2019-10-10. The listed applicant is Virak Orthopedics, LLC. The 510(k) number is K192465.
When did DigiFix Sterile Kit receive FDA 510(k) clearance?
DigiFix Sterile Kit received FDA 510(k) clearance on 2019-10-10, under 510(k) number K192465.
Who is the listed applicant for DigiFix Sterile Kit?
The FDA 510(k) record lists Virak Orthopedics, LLC as the applicant. This does not by itself establish the device manufacturer.
What is the FDA product code for DigiFix Sterile Kit?
The FDA product code for DigiFix Sterile Kit is JEC.
相關臨床試驗
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相關器械（代碼：JEC）
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。
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