FDA 510(k)

Invictus机器人导航仪器

K号: K232044 · 2023-10-06

决定日期2023-10-06

产品代码OLO

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决定实质等同

器械摘要

Invictus Robotic Navigation Instruments is the device name listed in this FDA 510(k) record. The listed applicant is Alphatec Spine, Inc.. It received FDA 510(k) clearance on 2023-10-06 under 510(k) number K232044. 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 Invictus Robotic Navigation Instruments?

Invictus Robotic Navigation Instruments is a medical device that received FDA 510(k) clearance on 2023-10-06. The listed applicant is Alphatec Spine, Inc.. The 510(k) number is K232044.

When did Invictus Robotic Navigation Instruments receive FDA 510(k) clearance?

Invictus Robotic Navigation Instruments received FDA 510(k) clearance on 2023-10-06, under 510(k) number K232044.

Who is the listed applicant for Invictus Robotic Navigation Instruments?

FDA 510(k)记录将Alphatec Spine, Inc.列为申请人。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 Invictus Robotic Navigation Instruments?

The FDA product code for Invictus Robotic Navigation Instruments is OLO.

列明Alphatec Spine, 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。

K261284Invictus® 矮身材脊柱固定系统；Invictus® 2.0 脊柱固定系统 K253216IntraOp 对位系统；CONTOUR3D 弯曲系统 K253615Invictus带系统 K252597Valence机器人导航系统；Valence机器人导航仪器（适用于StealthStation）K252842SafeOp 3：Neural Informatix System K251965Proximity 前颈椎板系统；节段性接骨板系统 (SPS)

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