FDA 510(k)

RESPONSE 导航仪器

K号: K203573 · 2021-02-04

决定日期2021-02-04

产品代码OLO

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

RESPONSE Navigation Instruments is the device name listed in this FDA 510(k) record. The listed applicant is OrthoPediatrics Corp.. It received FDA 510(k) clearance on 2021-02-04 under 510(k) number K203573. The device is classified under product code OLO. It was reviewed by the NE advisory panel. FDA Decision: Substantially Equivalent.

常见问题

What is the RESPONSE Navigation Instruments?

RESPONSE Navigation Instruments is a medical device that received FDA 510(k) clearance on 2021-02-04. The listed applicant is OrthoPediatrics Corp.. The 510(k) number is K203573.

When did RESPONSE Navigation Instruments receive FDA 510(k) clearance?

RESPONSE Navigation Instruments received FDA 510(k) clearance on 2021-02-04, under 510(k) number K203573.

Who is the listed applicant for RESPONSE Navigation Instruments?

FDA 510(k)记录将OrthoPediatrics Corp.列为申请人。这本身并不能确立该设备制造商的身份。

What is the FDA product code for RESPONSE Navigation Instruments?

The FDA product code for RESPONSE Navigation Instruments is OLO.

列明OrthoPediatrics Corp.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。

K261345儿童接骨平台股骨 K260323OrthoPediatrics® Locking Cannulated Blade Plate System K252600儿童小型-迷你平台 K251362PediFlex™ 弹性钉系统 K243963儿童髋关节平台 K250623儿童接骨平台胫骨儿童接骨平台股骨

查看所有 26 个设备 →

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。