GYDER® 髋關節系統
K 號：K243387 · 2025-01-29
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器材摘要
GYDER® Hip System is the device name listed in this FDA 510(k) record. The listed applicant is Gyder Surgical Pty, Ltd.. It received FDA 510(k) clearance on 2025-01-29 under 510(k) number K243387. The device is classified under product code OLO. It was reviewed by the NE advisory panel. FDA Decision: Substantially Equivalent.
常見問題
What is the GYDER® Hip System?
GYDER® Hip System is a medical device that received FDA 510(k) clearance on 2025-01-29. The listed applicant is Gyder Surgical Pty, Ltd.. The 510(k) number is K243387.
When did GYDER® Hip System receive FDA 510(k) clearance?
GYDER® Hip System received FDA 510(k) clearance on 2025-01-29, under 510(k) number K243387.
Who is the listed applicant for GYDER® Hip System?
The FDA 510(k) record lists Gyder Surgical Pty, Ltd. as the applicant. This does not by itself establish the device manufacturer.
What is the FDA product code for GYDER® Hip System?
The FDA product code for GYDER® Hip System is OLO.
相關臨床試驗
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相關器械（代碼：OLO）
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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