FDA 510(k)

CoNextions TR 腱修复系统

K号: K203855 · 2022-04-22

决定日期2022-04-22

产品代码GAQ

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决定实质等同

器械摘要

CoNextions TR Tendon Repair System is the device name listed in this FDA 510(k) record. The listed applicant is Conextions Medical. It received FDA 510(k) clearance on 2022-04-22 under 510(k) number K203855. The device is classified under product code GAQ. It was reviewed by the SU advisory panel. FDA Decision: Substantially Equivalent.

常见问题

What is the CoNextions TR Tendon Repair System?

CoNextions TR Tendon Repair System is a medical device that received FDA 510(k) clearance on 2022-04-22. The listed applicant is Conextions Medical. The 510(k) number is K203855.

When did CoNextions TR Tendon Repair System receive FDA 510(k) clearance?

CoNextions TR Tendon Repair System received FDA 510(k) clearance on 2022-04-22, under 510(k) number K203855.

Who is the listed applicant for CoNextions TR Tendon Repair System?

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

What is the FDA product code for CoNextions TR Tendon Repair System?

The FDA product code for CoNextions TR Tendon Repair System is GAQ.

列明Conextions Medical为申报人的其他记录

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