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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Thoracolumbosacral Pedicle Screw System
510(k) Number K210874
Device Name Reliance Spinal Screw 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
545 W 500 S.
Suite 100
Bountiful,  UT  84010
Correspondent Contact Bret M Berry
Regulation Number888.3070
Classification Product Code
NKB  
Subsequent Product Codes
KWP   KWQ  
Date Received03/24/2021
Decision Date 05/13/2021
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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