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U.S. Department of Health and Human Services

510(k) Premarket Notification

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Device Classification Name spinous process plate
510(k) Number K121924
Model 53-4016;53-4520;53-4106 THROUGH 53-4120
Device Name INTEGRA INTERSPINOUS PROCESS SYSTEM
Original Applicant
SEASPINE, INC.
2302 la mirada dr
vista,  CA  92081
Original Contact nick m cordaro
Regulation Number888.3050
Classification Product Code
PEK  
Date Received07/02/2012
Decision Date 09/04/2013
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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