FDA 510(k)

ATEC 后方导航椎间盘准备仪器

K号: K232345 · 2023-11-02

决定日期2023-11-02

产品代码OLO

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决定实质等同

器械摘要

ATEC Posterior Navigated Disc Prep Instruments is the device name listed in this FDA 510(k) record. The listed applicant is Alphatec Spine, Inc.. It received FDA 510(k) clearance on 2023-11-02 under 510(k) number K232345. 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 ATEC Posterior Navigated Disc Prep Instruments?

ATEC Posterior Navigated Disc Prep Instruments is a medical device that received FDA 510(k) clearance on 2023-11-02. The listed applicant is Alphatec Spine, Inc.. The 510(k) number is K232345.

When did ATEC Posterior Navigated Disc Prep Instruments receive FDA 510(k) clearance?

ATEC Posterior Navigated Disc Prep Instruments received FDA 510(k) clearance on 2023-11-02, under 510(k) number K232345.

Who is the listed applicant for ATEC Posterior Navigated Disc Prep Instruments?

FDA 510(k)记录将Alphatec Spine, Inc.列为申请人。这本身并不足以确立该设备制造商的身份。

What is the FDA product code for ATEC Posterior Navigated Disc Prep Instruments?

The FDA product code for ATEC Posterior Navigated Disc Prep Instruments is OLO.

列明Alphatec Spine, Inc.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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