FDA 510(k) Application Details - K162639

Device Classification Name	Orthosis, Cervical Pedicle Screw Spinal Fixation   More FDA Info for this Device
510(K) Number	K162639
Device Name	Orthosis, Cervical Pedicle Screw Spinal Fixation
Applicant	Spine Wave, Inc. 3 Enterprise Drive, Suite 210 Shelton, CT 06484 US Other 510(k) Applications for this Company
Contact	Sanja Jahr 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	09/22/2016
Decision Date	02/07/2017
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