TalarLift STS
K 號：K170624 · 2017-08-11
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器材摘要
TalarLift STS is the device name listed in this FDA 510(k) record. The listed applicant is Fusion Orthopedics, LLC. It received FDA 510(k) clearance on 2017-08-11 under 510(k) number K170624. The device is classified under product code HWC. It was reviewed by the OR advisory panel. Product code HWC falls under the category of Cardiovascular, which includes vascular grafts and cardiovascular implants. Devices in this category are subject to specific FDA regulatory requirements. FDA Decision: Substantially Equivalent.
常見問題
What is the TalarLift STS?
TalarLift STS is a medical device that received FDA 510(k) clearance on 2017-08-11. The listed applicant is Fusion Orthopedics, LLC. The 510(k) number is K170624.
When did TalarLift STS receive FDA 510(k) clearance?
TalarLift STS received FDA 510(k) clearance on 2017-08-11, under 510(k) number K170624.
Who is the listed applicant for TalarLift STS?
The FDA 510(k) record lists Fusion Orthopedics, LLC as the applicant. This does not by itself establish the device manufacturer.
What is the FDA product code for TalarLift STS?
The FDA product code for TalarLift STS is HWC. This falls under the Cardiovascular category.
相關臨床試驗
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其他以 Fusion Orthopedics, 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：HWC）
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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