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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, Lumbar
510(k) Number K113540
Device Name RELIANCE LUMBAR IBF SYSTEM
Applicant
Reliance Medical Systems, LLC
545 S. 500 W.
Suite 100
Bountiful,  UT  84010
Applicant Contact Bret M Berry
Correspondent
Reliance Medical Systems, LLC
545 S. 500 W.
Suite 100
Bountiful,  UT  84010
Correspondent Contact Bret M Berry
Regulation Number888.3080
Classification Product Code
MAX  
Date Received11/30/2011
Decision Date 03/12/2012
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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