FDA 510(k)

Evolution 脊柱导航仪器

K号: K250167 · 2025-08-18

决定日期2025-08-18

产品代码OLO

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决定实质等同

器械摘要

Evolution Spine Navigation Instruments is the device name listed in this FDA 510(k) record. The listed applicant is Evolution Spine. It received FDA 510(k) clearance on 2025-08-18 under 510(k) number K250167. 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 Evolution Spine Navigation Instruments?

Evolution Spine Navigation Instruments is a medical device that received FDA 510(k) clearance on 2025-08-18. The listed applicant is Evolution Spine. The 510(k) number is K250167.

When did Evolution Spine Navigation Instruments receive FDA 510(k) clearance?

Evolution Spine Navigation Instruments received FDA 510(k) clearance on 2025-08-18, under 510(k) number K250167.

Who is the listed applicant for Evolution Spine Navigation Instruments?

FDA 510(k)记录显示Evolution Spine为申请人。这本身并不能确立该设备制造商的身份。

What is the FDA product code for Evolution Spine Navigation Instruments?

The FDA product code for Evolution Spine Navigation Instruments is OLO.

列明Evolution Spine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。

K262094E3D™-C Interbody System K260038E3D™-C Interbody System K241846E3D™-C Interbody System K240368E3D™-A Interbody System K232432E3D™-A Interbody System K223146EVOLUTION SPINE 腰椎间融合系统

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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。