FDA 510(k)

xvision 脊柱系统

K号: K220905 · 2022-11-17

决定日期2022-11-17

产品代码SBF

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决定实质等同

器械摘要

xvision Spine System is the device name listed in this FDA 510(k) record. The listed applicant is Augmedics, Ltd.. It received FDA 510(k) clearance on 2022-11-17 under 510(k) number K220905. The device is classified under product code SBF. It was reviewed by the NE advisory panel. FDA Decision: Substantially Equivalent.

常见问题

What is the xvision Spine System?

xvision Spine System is a medical device that received FDA 510(k) clearance on 2022-11-17. The listed applicant is Augmedics, Ltd.. The 510(k) number is K220905.

When did xvision Spine System receive FDA 510(k) clearance?

xvision Spine System received FDA 510(k) clearance on 2022-11-17, under 510(k) number K220905.

Who is the listed applicant for xvision Spine System?

FDA 510(k)记录将Augmedics, Ltd.列为申请人。这本身并不能确立该设备制造商的身份。

What is the FDA product code for xvision Spine System?

The FDA product code for xvision Spine System is SBF.

列明Augmedics, Ltd.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。

K261854xvision 脊柱系统 K251639xvision 脊柱系统 K250255xvision 脊柱系统 K241481xvision 脊柱系统 K211188xvision 脊柱系统（XVS）K190929xvision 脊柱系统（XVS）

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官方来源

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