OsOpia 合成骨空隙填充剂
K号: K201546 · 2020-10-02
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申请人Revisios BV
决定日期2020-10-02
产品代码LYC
咨询委员会DE
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决定实质等同
器械摘要
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.
常见问题
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.
相关临床试验
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相关器械（代码：LYC）
关联记录通过名称、产品代码或其他元数据自动匹配。匹配不意味着已验证临床、科学、企业或监管关系；请查阅链接的官方来源。
官方来源
在 FDA 数据库中查看 →数据来源于FDA开放API。如需最新且权威的信息，请务必参考官方记录。
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