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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Intervertebral Fusion Device With Bone Graft, Cervical
510(k) Number K252781
Device Name MSFX MIKRON PEEK CAGES
Applicant
Mikron Makina Sanayi VE Tic. Ltd. Sti.
Ivedik Osb Mah. 1372. Sok. No:31 Yenimahalle
Yenimahalle,  TR 06378
Applicant Contact Mustafa Ekiz
Correspondent
Mikron Makina Sanayi VE Tic. Ltd. Sti.
Ivedik Osb Mah. 1372. Sok. No:31 Yenimahalle
Yenimahalle,  TR 06378
Correspondent Contact Mustafa Ekiz
Regulation Number888.3080
Classification Product Code
ODP  
Subsequent Product Code
MAX  
Date Received09/02/2025
Decision Date 12/19/2025
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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