FDA 510(k) Application Details - K131547

Device Classification Name	More FDA Info for this Device
510(K) Number	K131547
Device Name	LANX FUSION SYSTEM
Applicant	LANX, INC. 310 INTERLOCKEN PARKWAY SUITE 120 BROOMFIELD, CO 80021 US Other 510(k) Applications for this Company
Contact	Alan Burkholder Other 510(k) Applications for this Contact
Regulation Number	More FDA Info for this Regulation Number
Classification Product Code	OVD Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	05/29/2013
Decision Date	07/12/2013
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