OmniPore DUROMAX 外科植入物
K 號：K180249 · 2018-10-11
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器材摘要
OmniPore DUROMAX Surgical Implants is the device name listed in this FDA 510(k) record. The listed applicant is Matrix Surgical Holdings, LLC/Matrix Surgical USA. It received FDA 510(k) clearance on 2018-10-11 under 510(k) number K180249. The device is classified under product code JEY. It was reviewed by the DE advisory panel. FDA Decision: Substantially Equivalent.
常見問題
What is the OmniPore DUROMAX Surgical Implants?
OmniPore DUROMAX Surgical Implants is a medical device that received FDA 510(k) clearance on 2018-10-11. The listed applicant is Matrix Surgical Holdings, LLC/Matrix Surgical USA. The 510(k) number is K180249.
When did OmniPore DUROMAX Surgical Implants receive FDA 510(k) clearance?
OmniPore DUROMAX Surgical Implants received FDA 510(k) clearance on 2018-10-11, under 510(k) number K180249.
Who is the listed applicant for OmniPore DUROMAX Surgical Implants?
The FDA 510(k) record lists Matrix Surgical Holdings, LLC/Matrix Surgical USA as the applicant. This does not by itself establish the device manufacturer.
What is the FDA product code for OmniPore DUROMAX Surgical Implants?
The FDA product code for OmniPore DUROMAX Surgical Implants is JEY.
相關臨床試驗
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相關器械（代碼：JEY）
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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官方來源
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