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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Intervertebral Fusion Device With Bone Graft, Cervical
510(k) Number K172489
Device Name Reliance Cervical IBF 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 Number888.3080
Classification Product Code
ODP  
Subsequent Product Code
OVE  
Date Received08/17/2017
Decision Date 09/07/2017
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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