FDA 510(k)

VADER® 椎弓根系统导航仪器

K号: K230861 · 2023-06-27

决定日期2023-06-27

产品代码OLO

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决定实质等同

器械摘要

VADER® Pedicle System Navigated Instruments is the device name listed in this FDA 510(k) record. The listed applicant is Icotec AG. It received FDA 510(k) clearance on 2023-06-27 under 510(k) number K230861. 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 VADER® Pedicle System Navigated Instruments?

VADER® Pedicle System Navigated Instruments is a medical device that received FDA 510(k) clearance on 2023-06-27. The listed applicant is Icotec AG. The 510(k) number is K230861.

When did VADER® Pedicle System Navigated Instruments receive FDA 510(k) clearance?

VADER® Pedicle System Navigated Instruments received FDA 510(k) clearance on 2023-06-27, under 510(k) number K230861.

Who is the listed applicant for VADER® Pedicle System Navigated Instruments?

The FDA 510(k) record lists Icotec AG as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for VADER® Pedicle System Navigated Instruments?

The FDA product code for VADER® Pedicle System Navigated Instruments is OLO.

列明Icotec AG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。

K252327CMORE® CT 系统；CMORE® CT 系统导航工具 K242900VADER®椎弓根系统及VADER®one椎弓根系统 K233215icotec 颈前钢板系统 K232792icotec椎间融合器系统（icotec颈椎融合器，icotec PLIF腰椎融合器，icotec ETurn™ TLIF腰椎融合器）K232790KONG®-TL VBR系统和KONG® C VBR系统 K232628VADER® 椎弓根系统

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官方来源

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