FDA 510(k) Application Details - K133690

Device Classification Name	Orthosis, Spondyloisthesis Spinal Fixation   More FDA Info for this Device
510(K) Number	K133690
Device Name	Orthosis, Spondyloisthesis Spinal Fixation
Applicant	INNOVATIVE SURGICAL DESIGNS 2660 E. 2ND STREET #10 BLOOMINGTON, IN 47401 US Other 510(k) Applications for this Company
Contact	ED MORRIS 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	12/02/2013
Decision Date	05/07/2014
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