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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name thoracolumbosacral pedicle screw system
510(k) Number K122571
Device Name MALIBU SPINAL SYSTEM WITH THE DAYTONA DEFORMITY SYSTEM
Applicant
SEASPINE, INC.
2302 la Mirada Dr
VISTA,  CA  92081
Applicant Contact ETHEL BERNAL
Correspondent
SEASPINE, INC.
2302 la Mirada Dr
VISTA,  CA  92081
Correspondent 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 (SESE)
Regulation Medical Specialty Orthopedic
510k Review Panel Orthopedic
Summary Summary
Type Special
Reviewed by Third Party No
Combination Product No
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