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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, lumbar
510(k) Number K161405
Device Name 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  84119
Correspondent Contact William D. Jordan
Regulation Number888.3080
Classification Product Code
MAX  
Subsequent Product Code
ODP  
Date Received05/20/2016
Decision Date 08/19/2016
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Orthopedic
510k Review Panel Orthopedic
Summary Summary
Type Special
Reviewed by Third Party No
Combination Product No
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