移植物天然骨替代品
K号: K173188 · 2018-07-20
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决定日期2018-07-20
产品代码NPM
咨询委员会DE
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决定实质等同
器械摘要
The Graft Natural Bone Substitute is the device name listed in this FDA 510(k) record. The listed applicant is Purgo Biologics, Inc.. It received FDA 510(k) clearance on 2018-07-20 under 510(k) number K173188. The device is classified under product code NPM. It was reviewed by the DE advisory panel. FDA Decision: Substantially Equivalent.
常见问题
What is the The Graft Natural Bone Substitute?
The Graft Natural Bone Substitute is a medical device that received FDA 510(k) clearance on 2018-07-20. The listed applicant is Purgo Biologics, Inc.. The 510(k) number is K173188.
When did The Graft Natural Bone Substitute receive FDA 510(k) clearance?
The Graft Natural Bone Substitute received FDA 510(k) clearance on 2018-07-20, under 510(k) number K173188.
Who is the listed applicant for The Graft Natural Bone Substitute?
The FDA 510(k) record lists Purgo Biologics, Inc. as the applicant. This does not by itself establish the device manufacturer.
What is the FDA product code for The Graft Natural Bone Substitute?
The FDA product code for The Graft Natural Bone Substitute is NPM.
相关临床试验
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。
列明Purgo Biologics, Inc.为申报人的其他记录
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。
相关器械（代码：NPM）
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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