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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
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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