FDA 510(k)

FacetBRIDGE 系统

K号: K152137 · 2016-01-25

决定日期2016-01-25

产品代码MRW

决定实质等同

器械摘要

FacetBRIDGE System is the device name listed in this FDA 510(k) record. The listed applicant is Ldr Spine USA. It received FDA 510(k) clearance on 2016-01-25 under 510(k) number K152137. The device is classified under product code MRW. FDA Decision: Substantially Equivalent.

常见问题

What is the FacetBRIDGE System?

FacetBRIDGE System is a medical device that received FDA 510(k) clearance on 2016-01-25. The listed applicant is Ldr Spine USA. The 510(k) number is K152137.

When did FacetBRIDGE System receive FDA 510(k) clearance?

FacetBRIDGE System received FDA 510(k) clearance on 2016-01-25, under 510(k) number K152137.

Who is the listed applicant for FacetBRIDGE System?

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

What is the FDA product code for FacetBRIDGE System?

The FDA product code for FacetBRIDGE System is MRW.

列明Ldr Spine USA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。

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官方来源

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