FDA 510(k)

ROSA 脊柱

K号: K151511 · 2016-01-04

决定日期2016-01-04

产品代码OLO

咨询委员会NE

决定Substantially Equivalent

器械摘要

ROSA Spine is the device name listed in this FDA 510(k) record. The listed applicant is Medtech S.A. It received FDA 510(k) clearance on 2016-01-04 under 510(k) number K151511. 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 ROSA Spine?

ROSA Spine is a medical device that received FDA 510(k) clearance on 2016-01-04. The listed applicant is Medtech S.A. The 510(k) number is K151511.

When did ROSA Spine receive FDA 510(k) clearance?

ROSA Spine received FDA 510(k) clearance on 2016-01-04, under 510(k) number K151511.

Who is the listed applicant for ROSA Spine?

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

What is the FDA product code for ROSA Spine?

The FDA product code for ROSA Spine is OLO.

列明Medtech 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。

K200511ROSA ONE脑应用 K192173ROSA ONE 脊柱应用 K182848ROSA ONE 脊柱应用 K182417ROSA ONE脑应用 K172444ROSA BRAIN (v3.0.0.5)

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。