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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 (SESE)
Regulation Medical Specialty Orthopedic
510k Review Panel Orthopedic
summary summary
Type Special
Reviewed by Third Party No
Combination Product No
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