FDA 510(k) Application Details - K111115

Device Classification Name	Orthosis, Spinal Pedicle Fixation   More FDA Info for this Device
510(K) Number	K111115
Device Name	Orthosis, Spinal Pedicle Fixation
Applicant	CAPTIVA SPINE, INC 2361 NW 105TH LANE SUNRISE, FL 33322 US Other 510(k) Applications for this Company
Contact	JOHN SANDERS Other 510(k) Applications for this Contact
Regulation Number	888.3070   More FDA Info for this Regulation Number
Classification Product Code	MNI Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	04/21/2011
Decision Date	09/13/2011
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