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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 integrated fixation, cervical
510(k) Number K122771
Device Name SPINAL ELEMENTS CERVICAL INTERVERTEBRAL BODY FUSION SYSTEM
Original Applicant
SPINAL ELEMENTS, INC.
2744 loker ave. w. suite 100
carlsbad,  CA  92010
Original Contact benjamin a kimball
Regulation Number888.3080
Classification Product Code
OVE  
Date Received09/10/2012
Decision Date 01/10/2013
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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