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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Fastener, Fixation, Biodegradable, Soft Tissue
510(k) Number K240090
Device Name Argo Knotless GENESYS Anchor
Applicant
Conmed Corporation
525 French Rd.
Utica,  NY  13502
Applicant Contact Dionne Sanders
Correspondent
Conmed Corporation
525 French Rd.
Utica,  NY  13502
Correspondent Contact Dionne Sanders
Regulation Number888.3030
Classification Product Code
MAI  
Subsequent Product Code
MBI  
Date Received01/12/2024
Decision Date 03/05/2024
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Orthopedic
510k Review Panel Orthopedic
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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