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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 K113781
Model EPIPHANY AND PONTUS
Device Name PANTHEON SPINAL IBFD SYSTEM
Original Applicant
PANTHEON SPINAL
9442 capital of texas
hwy north - suite 900
austin,  TX  78759
Original Contact scott spann
Regulation Number888.3080
Classification Product Code
MAX  
Date Received12/22/2011
Decision Date 04/26/2013
Decision substantially equivalent (SE)
Classification Advisory Committee Orthopedic
Review Advisory Committee Orthopedic
Type Traditional
Reviewed by Third Party No
Expedited Review No
Combination Product No
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