紅點醫療的「優良趾骨外翻系統」
K 號：K220717 · 2022-06-09
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器材摘要
RedPoint Medical's Better Bunion System is the device name listed in this FDA 510(k) record. The listed applicant is Redpoint Medical, LLC. It received FDA 510(k) clearance on 2022-06-09 under 510(k) number K220717. The device is classified under product code PBF. It was reviewed by the OR advisory panel. FDA Decision: Substantially Equivalent.
常見問題
What is the RedPoint Medical's Better Bunion System?
RedPoint Medical's Better Bunion System is a medical device that received FDA 510(k) clearance on 2022-06-09. The listed applicant is Redpoint Medical, LLC. The 510(k) number is K220717.
When did RedPoint Medical's Better Bunion System receive FDA 510(k) clearance?
RedPoint Medical's Better Bunion System received FDA 510(k) clearance on 2022-06-09, under 510(k) number K220717.
Who is the listed applicant for RedPoint Medical's Better Bunion System?
The FDA 510(k) record lists Redpoint Medical, LLC as the applicant. This does not by itself establish the device manufacturer.
What is the FDA product code for RedPoint Medical's Better Bunion System?
The FDA product code for RedPoint Medical's Better Bunion System is PBF.
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：PBF）
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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