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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Appliance, Fixation, Spinal Interlaminal
510(k) Number K142867
Device Name Reliance Posterior Cervical-Thoracic System
Applicant
Reliance Medical Systems, LLC
545 W 500 S.
Suite 100
Bountiful,  UT  84010
Applicant Contact Bret M. Berry
Correspondent
Reliance Medical Systems, LLC
P.O. Box 1693
Bountiful,  UT  84010
Correspondent Contact Bret Berry
Regulation Number888.3050
Classification Product Code
KWP  
Date Received10/01/2014
Decision Date 04/29/2015
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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