FDA 510(k)

Precision Spine Navigation Instrumentation

K号: K181606 · 2019-09-27

决定日期2019-09-27

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

Precision Spine Navigation Instrumentation is the device name listed in this FDA 510(k) record. The listed applicant is Precision Spine, Inc.. It received FDA 510(k) clearance on 2019-09-27 under 510(k) number K181606. 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 Precision Spine Navigation Instrumentation?

Precision Spine Navigation Instrumentation is a medical device that received FDA 510(k) clearance on 2019-09-27. The listed applicant is Precision Spine, Inc.. The 510(k) number is K181606.

When did Precision Spine Navigation Instrumentation receive FDA 510(k) clearance?

Precision Spine Navigation Instrumentation received FDA 510(k) clearance on 2019-09-27, under 510(k) number K181606.

Who is the listed applicant for Precision Spine Navigation Instrumentation?

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

What is the FDA product code for Precision Spine Navigation Instrumentation?

The FDA product code for Precision Spine Navigation Instrumentation is OLO.

列明Precision Spine, Inc.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。

K250769Dakota LP系统 K242297Reform椎弓根螺钉系统 K231229S-COMP Reform® POCT 导航仪器 K220862E-GPS Navigated Instruments K213118Dakota ALIF系统 K220324AccuFit Lateral 2-Hole Plate

查看所有 17 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。