FDA 510(k)

Q 间体工具

K号: K252873 · 2026-02-06

决定日期2026-02-06

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

Q Interbody Instruments is the device name listed in this FDA 510(k) record. The listed applicant is K2m, Inc.. It received FDA 510(k) clearance on 2026-02-06 under 510(k) number K252873. 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 Q Interbody Instruments?

Q Interbody Instruments is a medical device that received FDA 510(k) clearance on 2026-02-06. The listed applicant is K2m, Inc.. The 510(k) number is K252873.

When did Q Interbody Instruments receive FDA 510(k) clearance?

Q Interbody Instruments received FDA 510(k) clearance on 2026-02-06, under 510(k) number K252873.

Who is the listed applicant for Q Interbody Instruments?

The FDA 510(k) record lists K2m, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Q Interbody Instruments?

The FDA product code for Q Interbody Instruments is OLO.

列明K2m, 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。

K260546Q 椎弓根工具 K253545伏尔甘脊柱系统 K211320CAPRI Corpectomy Cage System K202528Cannulated Power Driver Attachment K201006K2M 导航仪器 K193203MOJAVE 可扩张椎间融合系统

查看所有 27 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。