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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 K022160
Device Name XIA SPINAL SYSTEM
Original Applicant
HOWMEDICA OSTEONICS
59 route 17
allendale,  NJ  07401 1677
Original Contact karen ariemma
Regulation Number888.3070
Classification Product Code
MNI  
Subsequent Product Codes
KWP   KWQ   MNH  
Date Received07/03/2002
Decision Date 08/01/2002
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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