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FDA 510(k)

CoNextions TR Tendon Repair System

K-Number: K203855 · 2022-04-22

ApplicantConextions Medical
Decision Date2022-04-22
Product CodeGAQ
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

CoNextions TR Tendon Repair System is a medical device manufactured by Conextions Medical. It received FDA 510(k) clearance on 2022-04-22 under approval 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. It is manufactured by Conextions Medical. The 510(k) number is K203855.

When was CoNextions TR Tendon Repair System approved by the FDA?

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

What company makes CoNextions TR Tendon Repair System?

CoNextions TR Tendon Repair System is manufactured by Conextions Medical.

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

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

Related Clinical Trials

NCT04097145 Edwards PASCAL Transcatheter Valve Repair System Pivotal Clinical Trial RECRUITING NCT07277946 AtraUmatic Laparoscopic HerNia Repair Clinical Investigation to Evaluate the Safety and Performance of The ECLIPSIUM System for Mesh Fixation IDE RECRUITING NCT04503395 ShOrt neCK AAA RAndomized Trial - ESAR and FEVAR: SOCRATES RECRUITING NCT05735119 Embody Post-Market Clinical Follow-Up Study ACTIVE_NOT_RECRUITING NCT07598604 Early Mobilization and Equinus Correction in Spastic Cerebral Palsy NOT_YET_RECRUITING NCT03298477 EVAS2 IDE Prospective, Multicenter, Single Arm Safety and Effectiveness Confirmatory Study COMPLETED

Related PubMed Literature

PMID: 40781789 Resorbable Bio-Inductive Collagen Implant for Rotator Cuff Repair: What We Know, What We Need to Know, and the Path Forward. Orthopaedic surgery (2025)

Other Devices by Conextions Medical

K200028Coronet Soft Tissue Fixation System

Related Devices (Code: GAQ)

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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.

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