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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Plate, Fixation, Bone
510(k) Number K261830
Device Name FRAXION 3.5 Plate System (Various - See Catalog);FRAXION 4.5 Plate System (Various - See Catalog);FRAXION Mini Plate System (Various - See Catalog);FRAXION Bone Screw System (Various - See Catalog)
Applicant
Ortler Global Tibbi Gerecler Anonim Sirketi
Ivedikkoy Mah., 1492 Cadde, 17 B, 43, Yenimahalle
Ankara,  TR 06378
Applicant Contact TAHA CIBIR
Correspondent
Ortler Global Tibbi Gerecler Anonim Sirketi
Ivedikkoy Mah., 1492 Cadde, 17 B, 43, Yenimahalle
Ankara,  TR 06378
Correspondent Contact Victor Weaver
Regulation Number888.3030
Classification Product Code
HRS  
Subsequent Product Code
HWC  
Date Received06/02/2026
Decision Date 08/28/2026
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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