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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Intervertebral Fusion Device With Bone Graft, Cervical
510(k) Number K173453
Device Name Valeo® C+CSC with Lumen Interbody Fusion Device
Applicant
Amedica Corp.
1885 W. 2100 S.
Slat Lake City,  UT  84119
Applicant Contact Jason Parberry
Correspondent
Shanna Ryan
63 E 11400 S. 192
Sandy,  UT  84070
Correspondent Contact Shanna Ryan
Regulation Number888.3080
Classification Product Code
ODP  
Date Received11/06/2017
Decision Date 03/05/2018
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Orthopedic
510k Review Panel Orthopedic
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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