FDA 510(k)

Stealth® 脊柱夹具；ModuLeX® 股轴安装座

K号: K242464 · 2025-06-05

决定日期2025-06-05

产品代码OLO

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决定实质等同

器械摘要

Stealth™ Spine Clamps; ModuLeX™ Shank Mounts 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 2025-06-05 under 510(k) number K242464. 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™ Spine Clamps; ModuLeX™ Shank Mounts?

Stealth™ Spine Clamps; ModuLeX™ Shank Mounts is a medical device that received FDA 510(k) clearance on 2025-06-05. The listed applicant is Medtronic Navigation, Inc.. The 510(k) number is K242464.

When did Stealth™ Spine Clamps; ModuLeX™ Shank Mounts receive FDA 510(k) clearance?

Stealth™ Spine Clamps; ModuLeX™ Shank Mounts received FDA 510(k) clearance on 2025-06-05, under 510(k) number K242464.

Who is the listed applicant for Stealth™ Spine Clamps; ModuLeX™ Shank Mounts?

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™ Spine Clamps; ModuLeX™ Shank Mounts?

The FDA product code for Stealth™ Spine Clamps; ModuLeX™ Shank Mounts 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）K253381Stealth AXiS™手术系统及Stealth AXiS™脊柱临床应用 K251282StealthStation S8脊柱软件 K240465O-arm O2成像系统

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官方来源

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