FDA 510(k) Application Details - K151705

Device Classification Name	Orthosis, Cervical Pedicle Screw Spinal Fixation   More FDA Info for this Device
510(K) Number	K151705
Device Name	Orthosis, Cervical Pedicle Screw Spinal Fixation
Applicant	SPINAL ELEMENTS, INC. 3115 MELROSE DRIVE, STE 200 CARLSBAD, CA 92010 US Other 510(k) Applications for this Company
Contact	CECILIA SILVA 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	06/24/2015
Decision Date	09/03/2015
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