穩定骨科解決方案全膝系統
K 號：K183225 · 2019-02-15
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器材摘要
Stabil Orthopaedic Solutions Total Knee System is the device name listed in this FDA 510(k) record. The listed applicant is Stabil Orthopaedic Solutions, LLC. It received FDA 510(k) clearance on 2019-02-15 under 510(k) number K183225. The device is classified under product code JWH. It was reviewed by the OR advisory panel. FDA Decision: Substantially Equivalent.
常見問題
What is the Stabil Orthopaedic Solutions Total Knee System?
Stabil Orthopaedic Solutions Total Knee System is a medical device that received FDA 510(k) clearance on 2019-02-15. The listed applicant is Stabil Orthopaedic Solutions, LLC. The 510(k) number is K183225.
When did Stabil Orthopaedic Solutions Total Knee System receive FDA 510(k) clearance?
Stabil Orthopaedic Solutions Total Knee System received FDA 510(k) clearance on 2019-02-15, under 510(k) number K183225.
Who is the listed applicant for Stabil Orthopaedic Solutions Total Knee System?
The FDA 510(k) record lists Stabil Orthopaedic Solutions, LLC as the applicant. This does not by itself establish the device manufacturer.
What is the FDA product code for Stabil Orthopaedic Solutions Total Knee System?
The FDA product code for Stabil Orthopaedic Solutions Total Knee System is JWH.
相關臨床試驗
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相關器械（代碼：JWH）
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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