POYA 3.5mm 靜脈近端胫骨系統
K 號：K260228 · 2026-04-24
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器材摘要
POYA 3.5mm Medial Proximal Tibia 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 2026-04-24 under 510(k) number K260228. 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 POYA 3.5mm Medial Proximal Tibia System?
POYA 3.5mm Medial Proximal Tibia System is a medical device that received FDA 510(k) clearance on 2026-04-24. The listed applicant is Bonebridge AG. The 510(k) number is K260228.
When did POYA 3.5mm Medial Proximal Tibia System receive FDA 510(k) clearance?
POYA 3.5mm Medial Proximal Tibia System received FDA 510(k) clearance on 2026-04-24, under 510(k) number K260228.
Who is the listed applicant for POYA 3.5mm Medial Proximal Tibia 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 POYA 3.5mm Medial Proximal Tibia System?
The FDA product code for POYA 3.5mm Medial Proximal Tibia 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 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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