FDA 510(k) Application Details - K043349

Device Classification Name	Spinal Vertebral Body Replacement Device   More FDA Info for this Device
510(K) Number	K043349
Device Name	Spinal Vertebral Body Replacement Device
Applicant	LDR SPINE USA 4030 WEST BRAKER LANE SUITE 360 AUSTIN, TX 78759 US Other 510(k) Applications for this Company
Contact	BRAIN BURKINSHAW Other 510(k) Applications for this Contact
Regulation Number	888.3060   More FDA Info for this Regulation Number
Classification Product Code	MQP Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	12/06/2004
Decision Date	06/29/2005
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