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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 K123521
Device Name RELIANCE SPINAL SCREW SYSTEM
Applicant
Reliance Medical Systems, LLC
P.O. Box 1693
Bountiful,  UT  84010
Applicant Contact Bret M Berry
Correspondent
Reliance Medical Systems, LLC
P.O. Box 1693
Bountiful,  UT  84010
Correspondent Contact Bret M Berry
Regulation Number888.3070
Classification Product Code
MNI  
Subsequent Product Codes
KWP   KWQ   MNH  
Date Received11/15/2012
Decision Date 02/07/2013
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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