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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 K241657
Device Name MSFX MIKRON SPINAL FIXATION SYSTEM
Applicant
Mikron Makina Sanayi VE Ticaret Ltd. Sti.
Ivedik Osb Mah. 1372. Sok. No:31 Yenimahalle/Ankara/Turkey
Yenimahalle,  TR 06378
Applicant Contact Mustafa Ekiz
Correspondent
Mikron Makina Sanayi VE Ticaret Ltd. Sti.
Ivedik Osb Mah. 1372. Sok. No:31 Yenimahalle/Ankara/Turkey
Yenimahalle,  TR 06378
Correspondent Contact Mustafa Ekiz
Regulation Number888.3070
Classification Product Code
NKB  
Subsequent Product Code
KWP  
Date Received06/10/2024
Decision Date 09/30/2024
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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