FDA 510(k)

Stealth AXiS™手术系统及Stealth AXiS™脊柱临床应用

K号: K253381 · 2026-02-12

决定日期2026-02-12

产品代码OLO

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决定实质等同

器械摘要

Stealth AXiS™ Surgical System with Stealth AXiS™ Spine clinical application is the device name listed in this FDA 510(k) record. The listed applicant is Medtronic Navigation, Inc.. It received FDA 510(k) clearance on 2026-02-12 under 510(k) number K253381. 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 Stealth AXiS™ Surgical System with Stealth AXiS™ Spine clinical application?

Stealth AXiS™ Surgical System with Stealth AXiS™ Spine clinical application is a medical device that received FDA 510(k) clearance on 2026-02-12. The listed applicant is Medtronic Navigation, Inc.. The 510(k) number is K253381.

When did Stealth AXiS™ Surgical System with Stealth AXiS™ Spine clinical application receive FDA 510(k) clearance?

Stealth AXiS™ Surgical System with Stealth AXiS™ Spine clinical application received FDA 510(k) clearance on 2026-02-12, under 510(k) number K253381.

Who is the listed applicant for Stealth AXiS™ Surgical System with Stealth AXiS™ Spine clinical application?

The FDA 510(k) record lists Medtronic Navigation, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Stealth AXiS™ Surgical System with Stealth AXiS™ Spine clinical application?

The FDA product code for Stealth AXiS™ Surgical System with Stealth AXiS™ Spine clinical application is OLO.

列明Medtronic Navigation, 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。

K253379Stealth AXiS颅部临床应用 K253395Stealth AXiS™ ENT临床应用 K253391Visualase 冷却激光治疗仪系统（9735559）；Visualase 冷却激光治疗仪系统（9735560）；Visualase 冷却激光治疗仪系统（9735561）K251282StealthStation S8脊柱软件 K242464Stealth® 脊柱夹具；ModuLeX® 股轴安装座 K240465O-arm O2成像系统

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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。