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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 K081383
Device Name RELIANCE VBS SYSTEM
Applicant
Reliance Medical Systems, LLC
2647 Cassowary Cir.
Sandy,  UT  84092
Applicant Contact Bret M Berry
Correspondent
Reliance Medical Systems, LLC
2647 Cassowary Cir.
Sandy,  UT  84092
Correspondent Contact Bret M Berry
Regulation Number888.3060
Classification Product Code
MQP  
Date Received05/16/2008
Decision Date 07/02/2008
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Orthopedic
510k Review Panel Orthopedic
Summary Summary
Type Special
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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