New Search Back To Search Results Device Classification Name intervertebral fusion device with bone graft, lumbar 510(k) Number K143518 Device Name Valeo Spacer System and Valeo II Interbody Fusion Device System Applicant Amedica Corp. 1885 West 2100 South salt lake city, UT 84119 Applicant Contact william d. jordan Correspondent AMEDICA CORP. 1885 WEST 2100 SOUTH salt lake city, UT 84118 Correspondent Contact william d jordan Regulation Number 888.3080 Classification Product Code MAX Subsequent Product Code ODP Date Received 12/12/2014 Decision Date 10/02/2015 Decision substantially equivalent (SESE) Regulation Medical Specialty Orthopedic 510k Review Panel Orthopedic summary summary Type Traditional Reviewed by Third Party No Combination Product No