Endoform 塑形与重建基质
K号: K162461 · 2016-12-20
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决定日期2016-12-20
产品代码FTM
咨询委员会SU
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器械摘要
Endoform Plastics and Reconstructive Matrix is the device name listed in this FDA 510(k) record. The listed applicant is Aroa Biosurgery (Formerly Mesynthes Limited). It received FDA 510(k) clearance on 2016-12-20 under 510(k) number K162461. The device is classified under product code FTM. It was reviewed by the SU advisory panel. FDA Decision: Substantially Equivalent.
常见问题
What is the Endoform Plastics and Reconstructive Matrix?
Endoform Plastics and Reconstructive Matrix is a medical device that received FDA 510(k) clearance on 2016-12-20. The listed applicant is Aroa Biosurgery (Formerly Mesynthes Limited). The 510(k) number is K162461.
When did Endoform Plastics and Reconstructive Matrix receive FDA 510(k) clearance?
Endoform Plastics and Reconstructive Matrix received FDA 510(k) clearance on 2016-12-20, under 510(k) number K162461.
Who is the listed applicant for Endoform Plastics and Reconstructive Matrix?
The FDA 510(k) record lists Aroa Biosurgery (Formerly Mesynthes Limited) as the applicant. This does not by itself establish the device manufacturer.
What is the FDA product code for Endoform Plastics and Reconstructive Matrix?
The FDA product code for Endoform Plastics and Reconstructive Matrix is FTM.
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相关器械（代码：FTM）
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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