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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Thoracolumbosacral Pedicle Screw System
510(k) Number K262091
Device Name FRAXION Spinal Fixation System
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 Number888.3070
Classification Product Code
NKB  
Subsequent Product Codes
KWP   KWQ  
Date Received06/22/2026
Decision Date 09/17/2026
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Orthopedic
510k Review Panel Orthopedic
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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