Flex-Thread™ 遠端腓骨骨髓內釘系統
K 號：K202858 · 2021-01-22
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器材摘要
Flex-ThreadTM Distal Fibula Intramedullary Nail System is the device name listed in this FDA 510(k) record. The listed applicant is Conventus Orthopaedics, LLC. It received FDA 510(k) clearance on 2021-01-22 under 510(k) number K202858. The device is classified under product code HSB. It was reviewed by the OR advisory panel. FDA Decision: Substantially Equivalent.
常見問題
What is the Flex-ThreadTM Distal Fibula Intramedullary Nail System?
Flex-ThreadTM Distal Fibula Intramedullary Nail System is a medical device that received FDA 510(k) clearance on 2021-01-22. The listed applicant is Conventus Orthopaedics, LLC. The 510(k) number is K202858.
When did Flex-ThreadTM Distal Fibula Intramedullary Nail System receive FDA 510(k) clearance?
Flex-ThreadTM Distal Fibula Intramedullary Nail System received FDA 510(k) clearance on 2021-01-22, under 510(k) number K202858.
Who is the listed applicant for Flex-ThreadTM Distal Fibula Intramedullary Nail System?
The FDA 510(k) record lists Conventus Orthopaedics, LLC as the applicant. This does not by itself establish the device manufacturer.
What is the FDA product code for Flex-ThreadTM Distal Fibula Intramedullary Nail System?
The FDA product code for Flex-ThreadTM Distal Fibula Intramedullary Nail System is HSB.
相關臨床試驗
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相關器械（代碼：HSB）
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
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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