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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 intervertebral body
510(k) Number K122216
Device Name RELIANCE ANTERIOR CERVICAL PLATE SYSTEM
Applicant
Reliance Medical Systems, LLC
545 SOUTH 500 WEST
SUITE 100
BOUNTIFUL,  UT  84010
Applicant Contact Bret M Berry
Correspondent
Reliance Medical Systems, LLC
545 SOUTH 500 WEST
SUITE 100
BOUNTIFUL,  UT  84010
Correspondent Contact Bret M Berry
Regulation Number888.3060
Classification Product Code
KWQ  
Date Received07/25/2012
Decision Date 09/05/2012
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Orthopedic
510k Review Panel Orthopedic
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
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