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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Orthosis, Spinal Pedicle Fixation
510(k) Number K081978
Device Name RELIANCE SPINAL SCREW SYSTEM
Applicant
Reliance Medical Systems, LLC
2647 Cassowary Cir
Sandy,  UT  84092 -7116
Applicant Contact Bret M Berry
Correspondent
Reliance Medical Systems, LLC
2647 Cassowary Cir
Sandy,  UT  84092 -7116
Correspondent Contact Bret M Berry
Regulation Number888.3070
Classification Product Code
MNI  
Subsequent Product Codes
KWP   KWQ   MNH  
Date Received07/11/2008
Decision Date 03/26/2009
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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