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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Instrument, Surgical, Sonic And Accessory/Attachment
510(k) Number K022729
Device Name VENTED CEMENT RESTRICTOR
Applicant
Amedica Corp.
2116 S. Lakeline Dr.
Salt Lake City,  UT  84109
Applicant Contact ASHOK C KHANDKAR
Correspondent
Amedica Corp.
2116 S. Lakeline Dr.
Salt Lake City,  UT  84109
Correspondent Contact ASHOK C KHANDKAR
Regulation Number888.4580
Classification Product Code
JDX  
Date Received08/16/2002
Decision Date 11/14/2002
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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