FDA 510(k)

OBS锚定螺钉，Biokey锚定螺钉

K号: K202278 · 2021-01-08

决定日期2021-01-08

产品代码OAT

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决定实质等同

器械摘要

OBS Anchorage Screw, Biokey Anchorage Screw is the device name listed in this FDA 510(k) record. The listed applicant is Bomei Co, Ltd.. It received FDA 510(k) clearance on 2021-01-08 under 510(k) number K202278. The device is classified under product code OAT. It was reviewed by the DE advisory panel. FDA Decision: Substantially Equivalent.

常见问题

What is the OBS Anchorage Screw, Biokey Anchorage Screw?

OBS Anchorage Screw, Biokey Anchorage Screw is a medical device that received FDA 510(k) clearance on 2021-01-08. The listed applicant is Bomei Co, Ltd.. The 510(k) number is K202278.

When did OBS Anchorage Screw, Biokey Anchorage Screw receive FDA 510(k) clearance?

OBS Anchorage Screw, Biokey Anchorage Screw received FDA 510(k) clearance on 2021-01-08, under 510(k) number K202278.

Who is the listed applicant for OBS Anchorage Screw, Biokey Anchorage Screw?

The FDA 510(k) record lists Bomei Co, Ltd. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for OBS Anchorage Screw, Biokey Anchorage Screw?

The FDA product code for OBS Anchorage Screw, Biokey Anchorage Screw is OAT.

列明Bomei Co, Ltd.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。

K152297OBS锚定螺钉

官方来源

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