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FDA 510(k) Application Details - K171497
Device Classification Name
Orthosis, Spinal Pedicle Fixation
More FDA Info for this Device
510(K) Number
K171497
Device Name
Orthosis, Spinal Pedicle Fixation
Applicant
Mikron Makina Sanayi Ticaret Co. Ltd.
Agac Isleri Sanayi Sitesi 1372. Sokak No: 31-Ostim
Ankara 06378 TR
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Contact
Mesut KOSE
Other 510(k) Applications for this Contact
Regulation Number
888.3070
More FDA Info for this Regulation Number
Classification Product Code
MNI
Other 510(k) Applications for this Device
More FDA Info for this Product Code
Date Received
05/22/2017
Decision Date
10/12/2017
Decision
SESE - SUBST EQUIV
Classification Advisory Committee
OR - Orthopedic
Review Advisory Committee
OR - Orthopedic
Statement / Summary / Purged Status
Summary
Type
Traditional
Reviewed By Third Party
N
Expedited Review
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