HyperFlex® 趾骨矯正系統
K 號：K252997 · 2025-12-11
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器材摘要
HyperFlex® Bunion Correction System is the device name listed in this FDA 510(k) record. The listed applicant is Hyperflex Medical. It received FDA 510(k) clearance on 2025-12-11 under 510(k) number K252997. 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 HyperFlex® Bunion Correction System?
HyperFlex® Bunion Correction System is a medical device that received FDA 510(k) clearance on 2025-12-11. The listed applicant is Hyperflex Medical. The 510(k) number is K252997.
When did HyperFlex® Bunion Correction System receive FDA 510(k) clearance?
HyperFlex® Bunion Correction System received FDA 510(k) clearance on 2025-12-11, under 510(k) number K252997.
Who is the listed applicant for HyperFlex® Bunion Correction System?
The FDA 510(k) record lists Hyperflex Medical as the applicant. This does not by itself establish the device manufacturer.
What is the FDA product code for HyperFlex® Bunion Correction System?
The FDA product code for HyperFlex® Bunion Correction 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。
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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