BioBrace®
K号: K242187 · 2024-11-27
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决定日期2024-11-27
产品代码OWW
咨询委员会SU
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决定实质等同
器械摘要
BioBrace® is the device name listed in this FDA 510(k) record. The listed applicant is Conmed Corporation. It received FDA 510(k) clearance on 2024-11-27 under 510(k) number K242187. 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 BioBrace®?
BioBrace® is a medical device that received FDA 510(k) clearance on 2024-11-27. The listed applicant is Conmed Corporation. The 510(k) number is K242187.
When did BioBrace® receive FDA 510(k) clearance?
BioBrace® received FDA 510(k) clearance on 2024-11-27, under 510(k) number K242187.
Who is the listed applicant for BioBrace®?
The FDA 510(k) record lists Conmed Corporation as the applicant. This does not by itself establish the device manufacturer.
What is the FDA product code for BioBrace®?
The FDA product code for BioBrace® is OWW.
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Conmed Corporation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：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。
K251655VersaCoat 腱保护器（VTP-44G2）；VersaCoat 腱保护器（VTP-12G1）Alafair BiosciencesK250021RotiumNanofiber Solutions, LLCK241906BioBrace® 加强植入物Conmed CorporationK240817VersaWrapAlafair Biosciences, Inc.K222220SpinMedix 可吸收纤维膜Celestray Biotech Company, LLC.,K230316FlexBand; FlexPatch; FlexBand PlusInternational Life Sciences
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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