ClenchGuard
K号: K181005 · 2020-01-15
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器械摘要
ClenchGuard is the device name listed in this FDA 510(k) record. The listed applicant is Boyd Research, Inc.. It received FDA 510(k) clearance on 2020-01-15 under 510(k) number K181005. The device is classified under product code OBR. Product code OBR falls under the category of Orthopedic, which includes orthopedic implants, fixation devices, and surgical instruments. Devices in this category are subject to specific FDA regulatory requirements. FDA Decision: Substantially Equivalent.
常见问题
What is the ClenchGuard?
ClenchGuard is a medical device that received FDA 510(k) clearance on 2020-01-15. The listed applicant is Boyd Research, Inc.. The 510(k) number is K181005.
When did ClenchGuard receive FDA 510(k) clearance?
ClenchGuard received FDA 510(k) clearance on 2020-01-15, under 510(k) number K181005.
Who is the listed applicant for ClenchGuard?
The FDA 510(k) record lists Boyd Research, Inc. as the applicant. This does not by itself establish the device manufacturer.
What is the FDA product code for ClenchGuard?
The FDA product code for ClenchGuard is OBR. This falls under the Orthopedic category.
相关临床试验
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列明Boyd Research, 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：OBR）
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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