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U.S. Department of Health and Human Services

510(k) Premarket Notification

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Device Classification Name orthosis, spinal pedicle fixation, for degenerative disc disease
510(k) Number K120467
Device Name SPINAL ELEMENTS POSTERIOR CERVICAL/THORACIC SPINAL SYSTEM
Original Applicant
SPINAL ELEMENTS, INC.
2744 loker ave. w. suite 100
carlsbad,  CA  92008
Original Contact benjamin a kimball
Regulation Number888.3070
Classification Product Code
NKB  
Subsequent Product Codes
KWP   MNI  
Date Received02/15/2012
Decision Date 07/30/2012
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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