Parcus Twist AP 緝合釘
K 號：K183501 · 2019-03-15
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器材摘要
Parcus Twist AP Suture Anchors is the device name listed in this FDA 510(k) record. The listed applicant is Parcus Medical, LLC. It received FDA 510(k) clearance on 2019-03-15 under 510(k) number K183501. The device is classified under product code MAI. It was reviewed by the OR advisory panel. FDA Decision: Substantially Equivalent.
常見問題
What is the Parcus Twist AP Suture Anchors?
Parcus Twist AP Suture Anchors is a medical device that received FDA 510(k) clearance on 2019-03-15. The listed applicant is Parcus Medical, LLC. The 510(k) number is K183501.
When did Parcus Twist AP Suture Anchors receive FDA 510(k) clearance?
Parcus Twist AP Suture Anchors received FDA 510(k) clearance on 2019-03-15, under 510(k) number K183501.
Who is the listed applicant for Parcus Twist AP Suture Anchors?
The FDA 510(k) record lists Parcus Medical, LLC as the applicant. This does not by itself establish the device manufacturer.
What is the FDA product code for Parcus Twist AP Suture Anchors?
The FDA product code for Parcus Twist AP Suture Anchors is MAI.
相關臨床試驗
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其他以 Parcus Medical, LLC 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：MAI）
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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