FDA 510(k)

OsteoCool™ RF 烧灼系统；OsteoCool™ 2.0 RF 烧灼系统

K号: K253656 · 2026-06-05

决定日期2026-06-05

产品代码GEI

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决定实质等同

器械摘要

OsteoCool™ RF Ablation System; OsteoCool™ 2.0 RF Ablation System is the device name listed in this FDA 510(k) record. The listed applicant is Medtronic Sofamor Danek USA, Inc.. It received FDA 510(k) clearance on 2026-06-05 under 510(k) number K253656. The device is classified under product code GEI. It was reviewed by the SU advisory panel. FDA Decision: Substantially Equivalent.

常见问题

What is the OsteoCool™ RF Ablation System; OsteoCool™ 2.0 RF Ablation System?

OsteoCool™ RF Ablation System; OsteoCool™ 2.0 RF Ablation System is a medical device that received FDA 510(k) clearance on 2026-06-05. The listed applicant is Medtronic Sofamor Danek USA, Inc.. The 510(k) number is K253656.

When did OsteoCool™ RF Ablation System; OsteoCool™ 2.0 RF Ablation System receive FDA 510(k) clearance?

OsteoCool™ RF Ablation System; OsteoCool™ 2.0 RF Ablation System received FDA 510(k) clearance on 2026-06-05, under 510(k) number K253656.

Who is the listed applicant for OsteoCool™ RF Ablation System; OsteoCool™ 2.0 RF Ablation System?

FDA 510(k)记录中列出Medtronic Sofamor Danek USA, Inc.为申请人。这本身并不足以确立该设备制造商的身份。

What is the FDA product code for OsteoCool™ RF Ablation System; OsteoCool™ 2.0 RF Ablation System?

The FDA product code for OsteoCool™ RF Ablation System; OsteoCool™ 2.0 RF Ablation System is GEI.

列明Medtronic Sofamor Danek USA, Inc.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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相关器械（代码：GEI）

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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