FDA 510(k)

OsteoMed ExtremiFix 微型和小型系统托盘

K号: K202105 · 2020-10-29

决定日期2020-10-29

产品代码KCT

咨询委员会医疗设备监管文本翻译如下： HO 请注意，由于您没有提供具体的医疗设备监管文本内容，以上仅为示例。请提供具体的文本内容以便进行准确的翻译。

决定实质等同

器械摘要

OsteoMed ExtremiFix Mini & Small System Tray is the device name listed in this FDA 510(k) record. The listed applicant is Osteomed, LLC. It received FDA 510(k) clearance on 2020-10-29 under 510(k) number K202105. The device is classified under product code KCT. It was reviewed by the HO advisory panel. FDA Decision: Substantially Equivalent.

常见问题

What is the OsteoMed ExtremiFix Mini & Small System Tray?

OsteoMed ExtremiFix Mini & Small System Tray is a medical device that received FDA 510(k) clearance on 2020-10-29. The listed applicant is Osteomed, LLC. The 510(k) number is K202105.

When did OsteoMed ExtremiFix Mini & Small System Tray receive FDA 510(k) clearance?

OsteoMed ExtremiFix Mini & Small System Tray received FDA 510(k) clearance on 2020-10-29, under 510(k) number K202105.

Who is the listed applicant for OsteoMed ExtremiFix Mini & Small System Tray?

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

What is the FDA product code for OsteoMed ExtremiFix Mini & Small System Tray?

The FDA product code for OsteoMed ExtremiFix Mini & Small System Tray is KCT.

列明Osteomed, LLC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。

K212570OsteoPlan 系统 K202680OsteoMed ExtremiFix 微型和小型穿刺螺钉系统 K173391OsteoMed QuickFix Hybrid MMF 灭菌托盘 K163303OsteoMed ExtremiFix 中大型螺钉系统

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。