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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 K122571
Device Name MALIBU SPINAL SYSTEM WITH THE DAYTONA DEFORMITY SYSTEM
Original Applicant
SEASPINE, INC.
2302 la mirada dr
vista,  CA  92081
Original Contact ethel bernal
Regulation Number888.3070
Classification Product Code
NKB  
Subsequent Product Codes
KWP   MNH   MNI  
Date Received08/23/2012
Decision Date 12/12/2012
Decision substantially equivalent (SE)
Classification Advisory Committee Orthopedic
Review Advisory Committee Orthopedic
summary summary
Type Special
Reviewed by Third Party No
Expedited Review No
Combination Product No
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