FDA 510(k)

Synergy Cranial v2.2.9，StealthStation Cranial v3.1.4

K号: K221087 · 2022-06-10

决定日期2022-06-10

产品代码HAW

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决定实质等同

器械摘要

Synergy Cranial v2.2.9, StealthStation Cranial v3.1.4 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 2022-06-10 under 510(k) number K221087. The device is classified under product code HAW. It was reviewed by the NE advisory panel. FDA Decision: Substantially Equivalent.

常见问题

What is the Synergy Cranial v2.2.9, StealthStation Cranial v3.1.4?

Synergy Cranial v2.2.9, StealthStation Cranial v3.1.4 is a medical device that received FDA 510(k) clearance on 2022-06-10. The listed applicant is Medtronic Navigation, Inc.. The 510(k) number is K221087.

When did Synergy Cranial v2.2.9, StealthStation Cranial v3.1.4 receive FDA 510(k) clearance?

Synergy Cranial v2.2.9, StealthStation Cranial v3.1.4 received FDA 510(k) clearance on 2022-06-10, under 510(k) number K221087.

Who is the listed applicant for Synergy Cranial v2.2.9, StealthStation Cranial v3.1.4?

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 Synergy Cranial v2.2.9, StealthStation Cranial v3.1.4?

The FDA product code for Synergy Cranial v2.2.9, StealthStation Cranial v3.1.4 is HAW.

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 K242464Stealth® 脊柱夹具；ModuLeX® 股轴安装座

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官方来源

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