FDA 510(k) Application Details - K120760

Device Classification Name	Orthosis, Spondyloisthesis Spinal Fixation   More FDA Info for this Device
510(K) Number	K120760
Device Name	Orthosis, Spondyloisthesis Spinal Fixation
Applicant	LDR SPINE USA INC. 13785 RESEARCH BOULEVARD SUITE 200 AUSTIN, TX 78750 US Other 510(k) Applications for this Company
Contact	KIERSTEN SODERMAN 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	03/13/2012
Decision Date	06/27/2012
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