FDA 510(k)

OTS 髋关节

K号: K232140 · 2024-03-11

决定日期2024-03-11

产品代码OLO

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决定实质等同

器械摘要

OTS Hip is the device name listed in this FDA 510(k) record. The listed applicant is Ortoma AB. It received FDA 510(k) clearance on 2024-03-11 under 510(k) number K232140. 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 OTS Hip?

OTS Hip is a medical device that received FDA 510(k) clearance on 2024-03-11. The listed applicant is Ortoma AB. The 510(k) number is K232140.

When did OTS Hip receive FDA 510(k) clearance?

OTS Hip received FDA 510(k) clearance on 2024-03-11, under 510(k) number K232140.

Who is the listed applicant for OTS Hip?

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

What is the FDA product code for OTS Hip?

The FDA product code for OTS Hip is OLO.

列明Ortoma AB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。

K261852OTS 髋关节 K250086OTS 髋关节 K181449Ortoma治疗方案 - OTS

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。

器械摘要

常见问题

列明Ortoma AB为申报人的其他记录

相关器械（代码：OLO）

官方来源