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U.S. Department of Health and Human Services

510(k) Premarket Notification

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Device Classification Name appliance, fixation, spinal interlaminal
510(k) Number K051942
Device Name MALIBU SPINAL SYSTEM
Applicant
SEASPINE, INC.
2302 LA MIRADA DRIVE
VISTA,  CA  92081 -7862
Applicant Contact DIANA SMITH
Correspondent
SEASPINE, INC.
2302 LA MIRADA DRIVE
VISTA,  CA  92081 -7862
Correspondent Contact DIANA SMITH
Regulation Number888.3050
Classification Product Code
KWP  
Subsequent Product Codes
MNH   MNI   NKB  
Date Received07/15/2005
Decision Date 07/27/2005
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Orthopedic
510k Review Panel Orthopedic
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Recalls CDRH Recalls
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