FDA 510(k) Application Details - K151116

Device Classification Name	Orthosis, Spondyloisthesis Spinal Fixation   More FDA Info for this Device
510(K) Number	K151116
Device Name	Orthosis, Spondyloisthesis Spinal Fixation
Applicant	CAPTIVA SPINE 967 ALTERNATE A1A #1 JUPITER, FL 33477 US Other 510(k) Applications for this Company
Contact	TAMALA WAMPLER Other 510(k) Applications for this Contact
Regulation Number	888.3070   More FDA Info for this Regulation Number
Classification Product Code	MNH Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	04/27/2015
Decision Date	06/26/2015
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	OR - Orthopedic
Review Advisory Committee	OR - Orthopedic
Statement / Summary / Purged Status	Summary
Type	Special
Reviewed By Third Party	N
Expedited Review