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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 K260277
Device Name MIKRON TRAUMA BONE PLATE& SCREW SYSTEM
Applicant
Mikron Makina San. ve Tic. Ltd. Sti.
Ivedik Osb Agac Isleri San. Sit.1372. Sok. No:31
Yenimahalle,  TR 06378
Applicant Contact Mustafa Ekiz
Correspondent
Mikron Makina San. ve Tic. Ltd. Sti.
Ivedik Osb Agac Isleri San. Sit.1372. Sok. No:31
Yenimahalle,  TR 06378
Correspondent Contact Mustafa Ekiz
Regulation Number888.3030
Classification Product Code
HRS  
Subsequent Product Codes
HTN   HWC  
Date Received01/29/2026
Decision Date 08/13/2026
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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