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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 K031354
Device Name EBI OMEGA21 SPINAL FIXATION SYSTEM
Original Applicant
EBI, L.P.
399 jefferson road
parsippany,  NJ  07054
Original Contact frederic testa
Regulation Number888.3070
Classification Product Code
MNI  
Subsequent Product Codes
KWP   KWQ   MNH   NKB  
Date Received04/29/2003
Decision Date 08/06/2003
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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