EMPHASYS 髋關節系統
K 號：K243977 · 2025-01-22
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器材摘要
EMPHASYS Acetabular System is the device name listed in this FDA 510(k) record. The listed applicant is Depuy Ireland UC. It received FDA 510(k) clearance on 2025-01-22 under 510(k) number K243977. The device is classified under product code LPH. It was reviewed by the OR advisory panel. FDA Decision: Substantially Equivalent.
常見問題
What is the EMPHASYS Acetabular System?
EMPHASYS Acetabular System is a medical device that received FDA 510(k) clearance on 2025-01-22. The listed applicant is Depuy Ireland UC. The 510(k) number is K243977.
When did EMPHASYS Acetabular System receive FDA 510(k) clearance?
EMPHASYS Acetabular System received FDA 510(k) clearance on 2025-01-22, under 510(k) number K243977.
Who is the listed applicant for EMPHASYS Acetabular System?
The FDA 510(k) record lists Depuy Ireland UC as the applicant. This does not by itself establish the device manufacturer.
What is the FDA product code for EMPHASYS Acetabular System?
The FDA product code for EMPHASYS Acetabular System is LPH.
相關臨床試驗
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其他以 Depuy Ireland UC 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：LPH）
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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