FDA 510(k)

CoNextions TR Tendon Repair System

K-Number: K203855 · 2022-04-22

Decision Date2022-04-22

Product CodeGAQ

Advisory CommitteeSU

DecisionSubstantially Equivalent

Device Summary

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.

Frequently Asked Questions

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.

Other records listing Conextions Medical as applicant

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K200028Coronet Soft Tissue Fixation System

Related Devices (Code: GAQ)

K193209Wego-Stainless SteelFoosin Medical Supplies Inc., Ltd.K172146MERISTEELM/s. Meril Endo Surgery Private Limited.K170767Surgical Stainless Steel Suture, Stainless Steel SutureETHICON, Inc.

Official Source

View on FDA Database →

Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.