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 Other 510(k) Applications for this Company
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