FDA 510(k)

Camber 脊柱导航系统

K号: K220038 · 2022-04-29

决定日期2022-04-29

产品代码OLO

咨询委员会NE 请注意，您提供的文本“NE”不足以进行翻译，因为它不是一个完整的句子或描述。请提供完整的医疗设备监管文本，以便我能够进行准确的翻译。

决定实质等同

器械摘要

Camber Spine Navigation System is the device name listed in this FDA 510(k) record. The listed applicant is Camber Spine Technologies. It received FDA 510(k) clearance on 2022-04-29 under 510(k) number K220038. 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 Camber Spine Navigation System?

Camber Spine Navigation System is a medical device that received FDA 510(k) clearance on 2022-04-29. The listed applicant is Camber Spine Technologies. The 510(k) number is K220038.

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

Camber Spine Navigation System received FDA 510(k) clearance on 2022-04-29, under 510(k) number K220038.

Who is the listed applicant for Camber Spine Navigation System?

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

What is the FDA product code for Camber Spine Navigation System?

The FDA product code for Camber Spine Navigation System is OLO.

列明Camber 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。

K234077SPIRA® 腰椎前间隙器 K233972Camber 骶髂（SI）固定系统 K230942SPIRA® 腰椎后间隙器 K221324ENZA-O 钛合金侧前方腰椎椎体间融合术（ALIF）K223837SPIRA®-C 集成固定系统 K193153SPIRA-C 集成固定系统

查看所有 16 个设备 →

官方来源

在 FDA 数据库中查看 →

数据来源于FDA开放API。如需最新且权威的信息，请务必参考官方记录。