FDA 510(k) Application Details - K061462

Device Classification Name	Filler, Bone Void, Calcium Compound   More FDA Info for this Device
510(K) Number	K061462
Device Name	Filler, Bone Void, Calcium Compound
Applicant	LDR SPINE USA 4030 WEST BRAKER LANE SUITE 360 AUSTIN, TX 78759 US Other 510(k) Applications for this Company
Contact	EDWARD E NEWTON Other 510(k) Applications for this Contact
Regulation Number	888.3045   More FDA Info for this Regulation Number
Classification Product Code	MQV Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	05/26/2006
Decision Date	12/15/2006
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