STELLAR 髖關節
K 號：K232176 · 2023-11-02
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器材摘要
STELLAR Knee is the device name listed in this FDA 510(k) record. The listed applicant is Polarisar, Inc.. It received FDA 510(k) clearance on 2023-11-02 under 510(k) number K232176. The device is classified under product code SBF. It was reviewed by the NE advisory panel. FDA Decision: Substantially Equivalent.
常見問題
What is the STELLAR Knee?
STELLAR Knee is a medical device that received FDA 510(k) clearance on 2023-11-02. The listed applicant is Polarisar, Inc.. The 510(k) number is K232176.
When did STELLAR Knee receive FDA 510(k) clearance?
STELLAR Knee received FDA 510(k) clearance on 2023-11-02, under 510(k) number K232176.
Who is the listed applicant for STELLAR Knee?
The FDA 510(k) record lists Polarisar, Inc. as the applicant. This does not by itself establish the device manufacturer.
What is the FDA product code for STELLAR Knee?
The FDA product code for STELLAR Knee is SBF.
相關臨床試驗
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相關器械（代碼：SBF）
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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