VOLT™ 近端肱骨 3.5 套管系統
K 號：K233994 · 2024-07-26
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器材摘要
VOLT™ Proximal Humerus 3.5 Plating System is the device name listed in this FDA 510(k) record. The listed applicant is Synthes GmbH. It received FDA 510(k) clearance on 2024-07-26 under 510(k) number K233994. The device is classified under product code HRS. It was reviewed by the OR advisory panel. FDA Decision: Substantially Equivalent.
常見問題
What is the VOLT™ Proximal Humerus 3.5 Plating System?
VOLT™ Proximal Humerus 3.5 Plating System is a medical device that received FDA 510(k) clearance on 2024-07-26. The listed applicant is Synthes GmbH. The 510(k) number is K233994.
When did VOLT™ Proximal Humerus 3.5 Plating System receive FDA 510(k) clearance?
VOLT™ Proximal Humerus 3.5 Plating System received FDA 510(k) clearance on 2024-07-26, under 510(k) number K233994.
Who is the listed applicant for VOLT™ Proximal Humerus 3.5 Plating System?
The FDA 510(k) record lists Synthes GmbH as the applicant. This does not by itself establish the device manufacturer.
What is the FDA product code for VOLT™ Proximal Humerus 3.5 Plating System?
The FDA product code for VOLT™ Proximal Humerus 3.5 Plating System is HRS.
相關臨床試驗
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。
其他以 Synthes GmbH 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：HRS）
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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