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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Spinal Vertebral Body Replacement Device
510(k) Number K051525
Device Name ARX SPINAL SYSTEM
Applicant
Amedica Corp.
615 Arapeen Dr.
Salt Lake City,  UT  84108
Applicant Contact ROBERT M WOLFARTH
Correspondent
Amedica Corp.
615 Arapeen Dr.
Salt Lake City,  UT  84108
Correspondent Contact ROBERT M WOLFARTH
Regulation Number888.3060
Classification Product Code
MQP  
Date Received06/08/2005
Decision Date 02/17/2006
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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