FDA 510(k)

SafeOp 3：Neural Informatix Systeem

K号: K234092 · 2024-04-19

决定日期2024-04-19

产品代码GWF

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决定实质等同

器械摘要

SafeOp 3: Neural Informatix Systeem 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 2024-04-19 under 510(k) number K234092. The device is classified under product code GWF. It was reviewed by the NE advisory panel. FDA Decision: Substantially Equivalent.

常见问题

What is the SafeOp 3: Neural Informatix Systeem?

SafeOp 3: Neural Informatix Systeem is a medical device that received FDA 510(k) clearance on 2024-04-19. The listed applicant is Alphatec Spine, Inc.. The 510(k) number is K234092.

When did SafeOp 3: Neural Informatix Systeem receive FDA 510(k) clearance?

SafeOp 3: Neural Informatix Systeem received FDA 510(k) clearance on 2024-04-19, under 510(k) number K234092.

Who is the listed applicant for SafeOp 3: Neural Informatix Systeem?

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 SafeOp 3: Neural Informatix Systeem?

The FDA product code for SafeOp 3: Neural Informatix Systeem is GWF.

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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