FDA 510(k)

OMNIBotics Knee System

K号: K200888 · 2020-06-27

决定日期2020-06-27

产品代码OLO

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决定实质等同

器械摘要

OMNIBotics Knee System is the device name listed in this FDA 510(k) record. The listed applicant is Corin, Ltd.. It received FDA 510(k) clearance on 2020-06-27 under 510(k) number K200888. 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 OMNIBotics Knee System?

OMNIBotics Knee System is a medical device that received FDA 510(k) clearance on 2020-06-27. The listed applicant is Corin, Ltd.. The 510(k) number is K200888.

When did OMNIBotics Knee System receive FDA 510(k) clearance?

OMNIBotics Knee System received FDA 510(k) clearance on 2020-06-27, under 510(k) number K200888.

Who is the listed applicant for OMNIBotics Knee System?

FDA 510(k)记录将Corin, Ltd.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 OMNIBotics Knee System?

The FDA product code for OMNIBotics Knee System is OLO.

列明Corin, Ltd.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。

K261275Unity全膝关节系统，Unity膝关节无水泥CR股骨 K261576Icona髋关节假体 K201657Corin Ltd. 髋关节产品：Trinity® 髋臼系统，Trinity® PLUS 髋臼壳，MetaFix® 髋关节系统，TriFit® CF 和 TS 髋关节系统，TaperFit® 髋关节系统，Revival® 模块化髋关节系统，MiniHip®，Trinity® 双活动度，MobiliT，BiPolar-i，OMNI MOD® 髋关节系统，OMNI K1 和 K2 髋关节系统，OMNI 双极头，Corin Biolox Delta 陶瓷头，OMNI Delta 陶瓷头

官方来源

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