FDA 510(k)

DiversiVy® 关节突螺丝系统

K号: K253432 · 2026-03-19

决定日期2026-03-19

产品代码MRW

决定实质等同

器械摘要

DiversiVy™ Facet Screw System is the device name listed in this FDA 510(k) record. The listed applicant is Vy Spine, LLC. It received FDA 510(k) clearance on 2026-03-19 under 510(k) number K253432. The device is classified under product code MRW. FDA Decision: Substantially Equivalent.

常见问题

What is the DiversiVy™ Facet Screw System?

DiversiVy™ Facet Screw System is a medical device that received FDA 510(k) clearance on 2026-03-19. The listed applicant is Vy Spine, LLC. The 510(k) number is K253432.

When did DiversiVy™ Facet Screw System receive FDA 510(k) clearance?

DiversiVy™ Facet Screw System received FDA 510(k) clearance on 2026-03-19, under 510(k) number K253432.

Who is the listed applicant for DiversiVy™ Facet Screw System?

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

What is the FDA product code for DiversiVy™ Facet Screw System?

The FDA product code for DiversiVy™ Facet Screw System is MRW.

列明Vy Spine, LLC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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