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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 K993402
Device Name OPUS SPINAL SYSTEM
Original Applicant
HOWMEDICA OSTEONICS CORP.
59 route 17 south
allendale,  NJ  07401 -1677
Original Contact mary-catherine dillon
Regulation Number888.3070
Classification Product Code
MNI  
Subsequent Product Code
MNH  
Date Received10/08/1999
Decision Date 12/20/1999
Decision substantially equivalent (SESE)
Regulation Medical Specialty Orthopedic
510k Review Panel Orthopedic
summary summary
Type Traditional
Reviewed by Third Party No
Combination Product No
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