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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 K032394
Device Name STRYKER SPINE OASYS SYSTEM
Original Applicant
HOWMEDICA OSTEONICS CORP.
59 route 17 south
allendale,  NJ  07401 1677
Original Contact karen ariemma
Regulation Number888.3070
Classification Product Code
MNI  
Subsequent Product Code
KWP  
Date Received08/04/2003
Decision Date 02/20/2004
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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