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U.S. Department of Health and Human Services

510(k) Premarket Notification

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Device Classification Name orthosis, spine, plate, laminoplasty, metal
510(k) Number K130830
Model 52-XXXX / 95-2XXX
Device Name INTEGRA LAMINOPLASTY SYSTEM
Original Applicant
SEASPINE, INC.
2302 la mirada dr.
vista,  CA  92081 7862
Original Contact jeff brittan
Regulation Number888.3050
Classification Product Code
NQW  
Date Received03/26/2013
Decision Date 05/09/2013
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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