BioBrace植入物
K号: K203267 · 2021-04-30
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器械摘要
The BioBrace Implant is the device name listed in this FDA 510(k) record. The listed applicant is Biorez, Inc.. It received FDA 510(k) clearance on 2021-04-30 under 510(k) number K203267. The device is classified under product code OWW. It was reviewed by the SU advisory panel. FDA Decision: Substantially Equivalent.
常见问题
What is the The BioBrace Implant?
The BioBrace Implant is a medical device that received FDA 510(k) clearance on 2021-04-30. The listed applicant is Biorez, Inc.. The 510(k) number is K203267.
When did The BioBrace Implant receive FDA 510(k) clearance?
The BioBrace Implant received FDA 510(k) clearance on 2021-04-30, under 510(k) number K203267.
Who is the listed applicant for The BioBrace Implant?
The FDA 510(k) record lists Biorez, Inc. as the applicant. This does not by itself establish the device manufacturer.
What is the FDA product code for The BioBrace Implant?
The FDA product code for The BioBrace Implant is OWW.
相关临床试验
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相关器械（代码：OWW）
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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