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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 K121892
Device Name PHANTOM PLUS CERAMIC CAGE SYSTEM
Applicant
AMEDICA CORP.
615 ARAPEEN DRIVE
SALT LAKE CITY,  UT  84108
Applicant Contact ROBERT M WOLFARTH
Correspondent
AMEDICA CORP.
615 ARAPEEN DRIVE
SALT LAKE CITY,  UT  84108
Correspondent Contact ROBERT M WOLFARTH
Regulation Number888.3080
Classification Product Code
MAX  
Subsequent Product Code
ODP  
Date Received06/29/2012
Decision Date 08/24/2012
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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