FDA 510(k)

BIO-RAY A-1锚定螺钉系统

K号: K182929 · 2019-11-06

决定日期2019-11-06

产品代码OAT

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决定实质等同

器械摘要

BIO-RAY A-1 Anchor Screw System is the device name listed in this FDA 510(k) record. The listed applicant is Microware Precision Co., Ltd.. It received FDA 510(k) clearance on 2019-11-06 under 510(k) number K182929. 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 BIO-RAY A-1 Anchor Screw System?

BIO-RAY A-1 Anchor Screw System is a medical device that received FDA 510(k) clearance on 2019-11-06. The listed applicant is Microware Precision Co., Ltd.. The 510(k) number is K182929.

When did BIO-RAY A-1 Anchor Screw System receive FDA 510(k) clearance?

BIO-RAY A-1 Anchor Screw System received FDA 510(k) clearance on 2019-11-06, under 510(k) number K182929.

Who is the listed applicant for BIO-RAY A-1 Anchor Screw System?

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

What is the FDA product code for BIO-RAY A-1 Anchor Screw System?

The FDA product code for BIO-RAY A-1 Anchor Screw System is OAT.

列明Microware Precision 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。

K242814Tandry Q 锁定板系统 K230690Tandry 锁定板系统 K220360Tandry CMF 板系统 K220359Tandry 压缩螺钉系统 K171904Tandry 锁定板系统

官方来源

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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。