FDA 510(k) Application Details - K172495

Device Classification Name	Orthosis, Cervical Pedicle Screw Spinal Fixation   More FDA Info for this Device
510(K) Number	K172495
Device Name	Orthosis, Cervical Pedicle Screw Spinal Fixation
Applicant	Precision Spine, Inc. 2050 Executive Drive Pearl, MS 39208 US Other 510(k) Applications for this Company
Contact	Michael C. Dawson 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	08/18/2017
Decision Date	04/11/2018
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