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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Suture, Nonabsorbable, Steel, Monofilament And Multifilament, Sterile
510(k) Number K203855
Device Name CoNextions TR Tendon Repair System
Applicant
CoNextions Medical
150 North Wright Brothers Drive, Suite 560
Salt Lake City,  UT  84116
Applicant Contact Matthew Swift
Correspondent
Hogan Lovells US LLP
1735 Market Street, Suite 2300
Philadelphia,  PA  19103
Correspondent Contact Janice M. Hogan
Regulation Number878.4495
Classification Product Code
GAQ  
Date Received12/31/2020
Decision Date 04/22/2022
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General & Plastic Surgery
510k Review Panel General & Plastic Surgery
Summary Summary
Type Traditional
Clinical Trials NCT03622372
Reviewed by Third Party No
Combination Product No
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