FDA 510(k) Application Details - K102995

Device Classification Name	Orthosis, Spinal Pedicle Fixation   More FDA Info for this Device
510(K) Number	K102995
Device Name	Orthosis, Spinal Pedicle Fixation
Applicant	SPINE360 5000 PLAZA ON THE LAKE SUITE 305 AUSTIN, TX 78746 US Other 510(k) Applications for this Company
Contact	DAVE LAMB 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	10/08/2010
Decision Date	02/02/2011
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