FDA 510(k)

HOLO Portal™ 外科导航系统

K号: K231611 · 2023-08-31

决定日期2023-08-31

产品代码SBF

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决定实质等同

器械摘要

HOLO Portal™ Surgical Guidance System is the device name listed in this FDA 510(k) record. The listed applicant is Surgalign Spine Technologies. It received FDA 510(k) clearance on 2023-08-31 under 510(k) number K231611. 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 HOLO Portal™ Surgical Guidance System?

HOLO Portal™ Surgical Guidance System is a medical device that received FDA 510(k) clearance on 2023-08-31. The listed applicant is Surgalign Spine Technologies. The 510(k) number is K231611.

When did HOLO Portal™ Surgical Guidance System receive FDA 510(k) clearance?

HOLO Portal™ Surgical Guidance System received FDA 510(k) clearance on 2023-08-31, under 510(k) number K231611.

Who is the listed applicant for HOLO Portal™ Surgical Guidance System?

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

What is the FDA product code for HOLO Portal™ Surgical Guidance System?

The FDA product code for HOLO Portal™ Surgical Guidance System is SBF.

列明Surgalign Spine Technologies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。

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官方来源

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