FDA 510(k) Application Details - K130073

Device Classification Name	Orthosis, Spinal Pedicle Fixation   More FDA Info for this Device
510(K) Number	K130073
Device Name	Orthosis, Spinal Pedicle Fixation
Applicant	MIKRON MAKINA SANAYI VE TICARET LTD STI 80 LEICESTER WAY CHESAPEAKE CITY, MD 21915 US Other 510(k) Applications for this Company
Contact	OMAR DIKER 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	01/11/2013
Decision Date	12/16/2013
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