FDA 510(k) Application Details - K161478

Device Classification Name	Orthosis, Cervical Pedicle Screw Spinal Fixation   More FDA Info for this Device
510(K) Number	K161478
Device Name	Orthosis, Cervical Pedicle Screw Spinal Fixation
Applicant	Xenco Medical, LLC 9930 Mesa Rim Road San Diego, CA 92121 US Other 510(k) Applications for this Company
Contact	Gustavo Prado Other 510(k) Applications for this Contact
Regulation Number	000.0000   More FDA Info for this Regulation Number
Classification Product Code	NKG Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	05/31/2016
Decision Date	09/06/2016
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	OR - Orthopedic
Review Advisory Committee	OR - Orthopedic
Statement / Summary / Purged Status	Statement
Type	Traditional
Reviewed By Third Party	N
Expedited Review