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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 K120396
Device Name RELIANCE CERVICAL IBF SYSTEM
Applicant
RELIANCE MEDICAL SYSTEMS, LLC
545 south 500 west
suite 100
bountiful,  UT  84010
Contact bret m berry
Regulation Number888.3080
Classification Product Code
ODP  
Date Received02/08/2012
Decision Date 05/08/2012
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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