ShefaBone SCPC可吸收骨移植
K号: K153230 · 2016-07-14
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决定日期2016-07-14
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
ShefaBone SCPC Resorbable Bone Graft is the device name listed in this FDA 510(k) record. The listed applicant is The Implantech Inc./Shefabone. It received FDA 510(k) clearance on 2016-07-14 under 510(k) number K153230. 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 ShefaBone SCPC Resorbable Bone Graft?
ShefaBone SCPC Resorbable Bone Graft is a medical device that received FDA 510(k) clearance on 2016-07-14. The listed applicant is The Implantech Inc./Shefabone. The 510(k) number is K153230.
When did ShefaBone SCPC Resorbable Bone Graft receive FDA 510(k) clearance?
ShefaBone SCPC Resorbable Bone Graft received FDA 510(k) clearance on 2016-07-14, under 510(k) number K153230.
Who is the listed applicant for ShefaBone SCPC Resorbable Bone Graft?
The FDA 510(k) record lists The Implantech Inc./Shefabone as the applicant. This does not by itself establish the device manufacturer.
What is the FDA product code for ShefaBone SCPC Resorbable Bone Graft?
The FDA product code for ShefaBone SCPC Resorbable Bone Graft 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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