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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
Original Applicant
RELIANCE MEDICAL SYSTEMS, LLC
545 south 500 west
suite 100
bountiful,  UT  84010
Original Contact bret m berry
Regulation Number888.3060
Classification Product Code
KWQ  
Date Received07/25/2012
Decision Date 09/05/2012
Decision substantially equivalent (SE)
Classification Advisory Committee Orthopedic
Review Advisory Committee Orthopedic
summary summary
Type Traditional
Reviewed by Third Party No
Expedited Review No
Combination Product No
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