FDA 510(k)

椎间盘切除术导航准备工具和通用导航适配器套件

K号: K212756 · 2022-05-05

决定日期2022-05-05

产品代码OLO

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决定实质等同

器械摘要

Discectomy Navigation Ready Instruments and Universal Navigation Adaptor Set is the device name listed in this FDA 510(k) record. The listed applicant is Medos International SARL. It received FDA 510(k) clearance on 2022-05-05 under 510(k) number K212756. 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 Discectomy Navigation Ready Instruments and Universal Navigation Adaptor Set?

Discectomy Navigation Ready Instruments and Universal Navigation Adaptor Set is a medical device that received FDA 510(k) clearance on 2022-05-05. The listed applicant is Medos International SARL. The 510(k) number is K212756.

When did Discectomy Navigation Ready Instruments and Universal Navigation Adaptor Set receive FDA 510(k) clearance?

Discectomy Navigation Ready Instruments and Universal Navigation Adaptor Set received FDA 510(k) clearance on 2022-05-05, under 510(k) number K212756.

Who is the listed applicant for Discectomy Navigation Ready Instruments and Universal Navigation Adaptor Set?

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

What is the FDA product code for Discectomy Navigation Ready Instruments and Universal Navigation Adaptor Set?

The FDA product code for Discectomy Navigation Ready Instruments and Universal Navigation Adaptor Set is OLO.

列明Medos International SARL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。

K254157CROSSNAV 导航启用工具用于椎间盘准备和椎间 K260240SYMPHONY Navigation Ready Instruments K253249TriALTIS™ 脊柱系统 K243249TriALTIS™ 脊柱系统 K241893CROSSNAV 导航启用工具和UNAS 导航阵列 K242042TriALTIS™ 脊柱系统

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官方来源

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