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FDA 510(k)

QUATTRO Spinal system (Open Configuration); QUATTRO-GADGET Spinal system (MIS Configuration)

K号: K260362 · 2026-07-24

申请人MANTIZ Co., Ltd.
决定日期2026-07-24
产品代码NKB
咨询委员会OR
决定Substantially Equivalent

器械摘要

QUATTRO Spinal system (Open Configuration); QUATTRO-GADGET Spinal system (MIS Configuration) is the device name listed in this FDA 510(k) record. The listed applicant is MANTIZ Co., Ltd.. It received FDA 510(k) clearance on 2026-07-24 under 510(k) number K260362. The device is classified under product code NKB. It was reviewed by the OR advisory panel. FDA Decision: Substantially Equivalent.

常见问题

What is the QUATTRO Spinal system (Open Configuration); QUATTRO-GADGET Spinal system (MIS Configuration)?

QUATTRO Spinal system (Open Configuration); QUATTRO-GADGET Spinal system (MIS Configuration) is a medical device that received FDA 510(k) clearance on 2026-07-24. The listed applicant is MANTIZ Co., Ltd.. The 510(k) number is K260362.

When did QUATTRO Spinal system (Open Configuration); QUATTRO-GADGET Spinal system (MIS Configuration) receive FDA 510(k) clearance?

QUATTRO Spinal system (Open Configuration); QUATTRO-GADGET Spinal system (MIS Configuration) received FDA 510(k) clearance on 2026-07-24, under 510(k) number K260362.

谁是QUATTRO脊柱系统（开放配置）；QUATTRO-GADGET脊柱系统（微创配置）的列名申请人？

The FDA 510(k) record lists MANTIZ Co., Ltd. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for QUATTRO Spinal system (Open Configuration); QUATTRO-GADGET Spinal system (MIS Configuration)?

QUATTRO脊柱系统（开放配置）；QUATTRO-GADGET脊柱系统（MIS配置）的FDA产品代码是NKB。

相关临床试验

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相关器械（代码：NKB）

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。

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