FDA 510(k)

CenterMed患者匹配辅助手术规划（ASP）系统

K号: K201353 · 2021-06-28

决定日期2021-06-28

产品代码DZJ

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决定实质等同

器械摘要

CenterMed Patient Matched Assisted Surgical Planning (ASP) System is the device name listed in this FDA 510(k) record. The listed applicant is Centermed, Inc.. It received FDA 510(k) clearance on 2021-06-28 under 510(k) number K201353. The device is classified under product code DZJ. It was reviewed by the DE advisory panel. FDA Decision: Substantially Equivalent.

常见问题

What is the CenterMed Patient Matched Assisted Surgical Planning (ASP) System?

CenterMed Patient Matched Assisted Surgical Planning (ASP) System is a medical device that received FDA 510(k) clearance on 2021-06-28. The listed applicant is Centermed, Inc.. The 510(k) number is K201353.

When did CenterMed Patient Matched Assisted Surgical Planning (ASP) System receive FDA 510(k) clearance?

CenterMed Patient Matched Assisted Surgical Planning (ASP) System received FDA 510(k) clearance on 2021-06-28, under 510(k) number K201353.

Who is the listed applicant for CenterMed Patient Matched Assisted Surgical Planning (ASP) System?

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

What is the FDA product code for CenterMed Patient Matched Assisted Surgical Planning (ASP) System?

The FDA product code for CenterMed Patient Matched Assisted Surgical Planning (ASP) System is DZJ.

列明Centermed, 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。

K211614CenterMed患者匹配辅助手术规划（ASP）系统

官方来源

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