SALGINA 2.5mm 遠端桡骨系統
K 號：K261351 · 2026-06-26
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器材摘要
SALGINA 2.5mm Distal Radius System is the device name listed in this FDA 510(k) record. The listed applicant is Bonebridge AG. It received FDA 510(k) clearance on 2026-06-26 under 510(k) number K261351. 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 SALGINA 2.5mm Distal Radius System?
SALGINA 2.5mm Distal Radius System is a medical device that received FDA 510(k) clearance on 2026-06-26. The listed applicant is Bonebridge AG. The 510(k) number is K261351.
When did SALGINA 2.5mm Distal Radius System receive FDA 510(k) clearance?
SALGINA 2.5mm Distal Radius System received FDA 510(k) clearance on 2026-06-26, under 510(k) number K261351.
Who is the listed applicant for SALGINA 2.5mm Distal Radius System?
The FDA 510(k) record lists Bonebridge AG as the applicant. This does not by itself establish the device manufacturer.
What is the FDA product code for SALGINA 2.5mm Distal Radius System?
The FDA product code for SALGINA 2.5mm Distal Radius System is HRS.
相關臨床試驗
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其他以 Bonebridge AG 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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