FDA 510(k)

SpineGuard DSG Zavation 螺钉系统

K号: K162884 · 2017-01-12

决定日期2017-01-12

产品代码HBG

咨询委员会NE 请注意，您提供的文本“NE”不足以进行翻译，因为它不是一个完整的句子或描述。请提供完整的医疗设备监管文本，以便我能够进行准确的翻译。

决定实质等同

器械摘要

SpineGuard DSG Zavation Screw System is the device name listed in this FDA 510(k) record. The listed applicant is Spineguard S.A.. It received FDA 510(k) clearance on 2017-01-12 under 510(k) number K162884. The device is classified under product code HBG. It was reviewed by the NE advisory panel. FDA Decision: Substantially Equivalent.

常见问题

What is the SpineGuard DSG Zavation Screw System?

SpineGuard DSG Zavation Screw System is a medical device that received FDA 510(k) clearance on 2017-01-12. The listed applicant is Spineguard S.A.. The 510(k) number is K162884.

When did SpineGuard DSG Zavation Screw System receive FDA 510(k) clearance?

SpineGuard DSG Zavation Screw System received FDA 510(k) clearance on 2017-01-12, under 510(k) number K162884.

Who is the listed applicant for SpineGuard DSG Zavation Screw System?

The FDA 510(k) record lists Spineguard S.A. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for SpineGuard DSG Zavation Screw System?

The FDA product code for SpineGuard DSG Zavation Screw System is HBG.

列明Spineguard S.A.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。

K220160PediGuard 穿孔螺纹 K201454DSG 连接技术 K152747DSG 螺纹钻系统

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。