FDA 510(k)

Orthodontic Fixation Screw [Smart Anchor Miniscrew]

K号: K191041 · 2020-08-28

决定日期2020-08-28

产品代码OAT

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决定实质等同

器械摘要

Orthodontic Fixation Screw [Smart Anchor Miniscrew] is the device name listed in this FDA 510(k) record. The listed applicant is Gni Co., Ltd.. It received FDA 510(k) clearance on 2020-08-28 under 510(k) number K191041. 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 Orthodontic Fixation Screw [Smart Anchor Miniscrew]?

Orthodontic Fixation Screw [Smart Anchor Miniscrew] is a medical device that received FDA 510(k) clearance on 2020-08-28. The listed applicant is Gni Co., Ltd.. The 510(k) number is K191041.

When did Orthodontic Fixation Screw [Smart Anchor Miniscrew] receive FDA 510(k) clearance?

Orthodontic Fixation Screw [Smart Anchor Miniscrew] received FDA 510(k) clearance on 2020-08-28, under 510(k) number K191041.

Who is the listed applicant for Orthodontic Fixation Screw [Smart Anchor Miniscrew]?

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

What is the FDA product code for Orthodontic Fixation Screw [Smart Anchor Miniscrew]?

The FDA product code for Orthodontic Fixation Screw [Smart Anchor Miniscrew] is OAT.

列明Gni 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。

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