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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
510(k) Number K080143
Device Name MODIFICATION TO STRYKER SPINE OASYS SYSTEM
Original Applicant
STRYKER SPINE
2 pearl court
allendale,  NJ  07401
Original Contact curtis truesdale
Regulation Number888.3070
Classification Product Code
MNI  
Subsequent Product Code
KWP  
Date Received01/22/2008
Decision Date 02/14/2008
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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