FDA 510(k)

NovoStitch Pro 半月板修复系统

K号: K180531 · 2018-03-29

决定日期2018-03-29

产品代码GAT

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决定实质等同

器械摘要

NovoStitch Pro Meniscal Repair System is the device name listed in this FDA 510(k) record. The listed applicant is Ceterix Orthopaedics, Inc.. It received FDA 510(k) clearance on 2018-03-29 under 510(k) number K180531. The device is classified under product code GAT. It was reviewed by the SU advisory panel. FDA Decision: Substantially Equivalent.

常见问题

What is the NovoStitch Pro Meniscal Repair System?

NovoStitch Pro Meniscal Repair System is a medical device that received FDA 510(k) clearance on 2018-03-29. The listed applicant is Ceterix Orthopaedics, Inc.. The 510(k) number is K180531.

When did NovoStitch Pro Meniscal Repair System receive FDA 510(k) clearance?

NovoStitch Pro Meniscal Repair System received FDA 510(k) clearance on 2018-03-29, under 510(k) number K180531.

Who is the listed applicant for NovoStitch Pro Meniscal Repair System?

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

What is the FDA product code for NovoStitch Pro Meniscal Repair System?

The FDA product code for NovoStitch Pro Meniscal Repair System is GAT.

列明Ceterix Orthopaedics, 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。

K181772NovoStitch Pro 半月板修复系统，CTX-A004（尺寸 0）

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