FDA 510(k)

IntraOp 对位系统

K号: K240199 · 2024-05-22

决定日期2024-05-22

产品代码OWB

咨询委员会RA

决定实质等同

器械摘要

IntraOp Alignment System 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 2024-05-22 under 510(k) number K240199. The device is classified under product code OWB. It was reviewed by the RA advisory panel. FDA Decision: Substantially Equivalent.

常见问题

What is the IntraOp Alignment System?

IntraOp Alignment System is a medical device that received FDA 510(k) clearance on 2024-05-22. The listed applicant is Alphatec Spine, Inc.. The 510(k) number is K240199.

When did IntraOp Alignment System receive FDA 510(k) clearance?

IntraOp Alignment System received FDA 510(k) clearance on 2024-05-22, under 510(k) number K240199.

Who is the listed applicant for IntraOp Alignment System?

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 IntraOp Alignment System?

The FDA product code for IntraOp Alignment System is OWB.

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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官方来源

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