FDA 510(k)

SeaSpine Shoreline ACS - Anterior Cervical Standalone System

K号: K161081 · 2016-09-14

决定日期2016-09-14

产品代码OVE

咨询委员会OR

决定Substantially Equivalent

器械摘要

SeaSpine Shoreline ACS - Anterior Cervical Standalone System is the device name listed in this FDA 510(k) record. The listed applicant is SeaSpine Orthopedics Corporation. It received FDA 510(k) clearance on 2016-09-14 under 510(k) number K161081. The device is classified under product code OVE. It was reviewed by the OR advisory panel. FDA Decision: Substantially Equivalent.

常见问题

What is the SeaSpine Shoreline ACS - Anterior Cervical Standalone System?

SeaSpine Shoreline ACS - Anterior Cervical Standalone System is a medical device that received FDA 510(k) clearance on 2016-09-14. The listed applicant is SeaSpine Orthopedics Corporation. The 510(k) number is K161081.

When did SeaSpine Shoreline ACS - Anterior Cervical Standalone System receive FDA 510(k) clearance?

SeaSpine Shoreline ACS - Anterior Cervical Standalone System received FDA 510(k) clearance on 2016-09-14, under 510(k) number K161081.

Who is the listed applicant for SeaSpine Shoreline ACS - Anterior Cervical Standalone System?

The FDA 510(k) record lists SeaSpine Orthopedics Corporation as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for SeaSpine Shoreline ACS - Anterior Cervical Standalone System?

The FDA product code for SeaSpine Shoreline ACS - Anterior Cervical Standalone System is OVE.

列明SeaSpine Orthopedics Corporation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。

查看所有 67 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。