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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 K113518
Model 01-72000-05, 01-72000-06, 01-72000-07, 01-72000-08, 01-72000-09
Device Name ARENA-C CERVICAL INTERVERTEBRAL BODY FUSION SYSTEM
Original Applicant
SPINEFRONTIER, INC.
500 cummings center
suite 3500
beverly,  MA  01915
Original Contact christopher chang
Regulation Number888.3080
Classification Product Code
ODP  
Date Received11/29/2011
Decision Date 02/16/2012
Decision substantially equivalent (SE)
Classification Advisory Committee Orthopedic
Review Advisory Committee Orthopedic
summary summary
Type Abbreviated
Reviewed by Third Party No
Expedited Review No
Combination Product No
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