FDA 510(k)

Anatase 脊柱手术导航系统及Remex 脊柱手术导航系统II

K号: K251315 · 2025-05-29

决定日期2025-05-29

产品代码OLO

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决定实质等同

器械摘要

Anatase Spine Surgery Navigation System and Remex Spine Surgery Navigation System II is the device name listed in this FDA 510(k) record. The listed applicant is Remex Medical Corp.. It received FDA 510(k) clearance on 2025-05-29 under 510(k) number K251315. 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 Anatase Spine Surgery Navigation System and Remex Spine Surgery Navigation System II?

Anatase Spine Surgery Navigation System and Remex Spine Surgery Navigation System II is a medical device that received FDA 510(k) clearance on 2025-05-29. The listed applicant is Remex Medical Corp.. The 510(k) number is K251315.

When did Anatase Spine Surgery Navigation System and Remex Spine Surgery Navigation System II receive FDA 510(k) clearance?

Anatase Spine Surgery Navigation System and Remex Spine Surgery Navigation System II received FDA 510(k) clearance on 2025-05-29, under 510(k) number K251315.

Who is the listed applicant for Anatase Spine Surgery Navigation System and Remex Spine Surgery Navigation System II?

FDA 510(k)记录将Remex Medical Corp.列为申请人。这本身并不能确立该设备制造商的身份。

What is the FDA product code for Anatase Spine Surgery Navigation System and Remex Spine Surgery Navigation System II?

The FDA product code for Anatase Spine Surgery Navigation System and Remex Spine Surgery Navigation System II is OLO.

列明Remex Medical Corp.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。

K262506Remex脊柱外科导航 - 通用工具 K243560Remex脊柱外科导航仪器 K241625Anatase Navi 可用仪器 K233513Remex脊柱外科导航系统II K230783Anatase 脊柱手术导航系统

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。