OsOpia 合成骨空洞填充物
K 號：K201546 · 2020-10-02
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器材摘要
OsOpia Synthetic Bone Void Filler is the device name listed in this FDA 510(k) record. The listed applicant is Revisios BV. It received FDA 510(k) clearance on 2020-10-02 under 510(k) number K201546. The device is classified under product code LYC. It was reviewed by the DE advisory panel. FDA Decision: Substantially Equivalent.
常見問題
What is the OsOpia Synthetic Bone Void Filler?
OsOpia Synthetic Bone Void Filler is a medical device that received FDA 510(k) clearance on 2020-10-02. The listed applicant is Revisios BV. The 510(k) number is K201546.
When did OsOpia Synthetic Bone Void Filler receive FDA 510(k) clearance?
OsOpia Synthetic Bone Void Filler received FDA 510(k) clearance on 2020-10-02, under 510(k) number K201546.
Who is the listed applicant for OsOpia Synthetic Bone Void Filler?
The FDA 510(k) record lists Revisios BV as the applicant. This does not by itself establish the device manufacturer.
What is the FDA product code for OsOpia Synthetic Bone Void Filler?
The FDA product code for OsOpia Synthetic Bone Void Filler is LYC.
相關臨床試驗
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相關器械（代碼：LYC）
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
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