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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 interlaminal
510(k) Number K122292
Device Name RELIANCE POSTERIOR CERVICAL- THORACIC SYSTEM
Original Applicant
RELIANCE MEDICAL SYSTEMS, LLC
545 west 500 south
suite 100
bountiful,  UT  84010
Original Contact bret m berry
Regulation Number888.3050
Classification Product Code
KWP  
Subsequent Product Codes
MNH   MNI  
Date Received07/31/2012
Decision Date 10/24/2012
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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