CoLumbo C-Spine
K号: K254015 · 2026-04-01
广告
器械摘要
CoLumbo C-Spine is the device name listed in this FDA 510(k) record. The listed applicant is Smart Soft Healthcare AD. It received FDA 510(k) clearance on 2026-04-01 under 510(k) number K254015. The device is classified under product code QIH. It was reviewed by the RA advisory panel. FDA Decision: Substantially Equivalent.
常见问题
What is the CoLumbo C-Spine?
CoLumbo C-Spine is a medical device that received FDA 510(k) clearance on 2026-04-01. The listed applicant is Smart Soft Healthcare AD. The 510(k) number is K254015.
When did CoLumbo C-Spine receive FDA 510(k) clearance?
CoLumbo C-Spine received FDA 510(k) clearance on 2026-04-01, under 510(k) number K254015.
Who is the listed applicant for CoLumbo C-Spine?
The FDA 510(k) record lists Smart Soft Healthcare AD as the applicant. This does not by itself establish the device manufacturer.
What is the FDA product code for CoLumbo C-Spine?
The FDA product code for CoLumbo C-Spine is QIH.
相关临床试验
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。
列明Smart Soft Healthcare AD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。
相关器械（代码：QIH）
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。
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。
广告