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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Mesh, Surgical, Polymeric, Resorbable, Orthopedics, Reinforcement Of Ligament
510(k) Number K260317
Device Name Artelon Convenience Kits
Applicant
International Life Sciences
8601 Dunwoody Pl. #250
Sandy Springs,  GA  30350
Applicant Contact Rachel Roberts
Correspondent
International Life Sciences
8601 Dunwoody Pl. #250
Sandy Springs,  GA  30350
Correspondent Contact Rachel Roberts
Regulation Number878.3300
Classification Product Code
QWJ  
Subsequent Product Codes
MBI   OWW  
Date Received01/30/2026
Decision Date 04/09/2026
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General & Plastic Surgery
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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