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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 K001037
Device Name MODIFICATION TO EBI SPINELINK SYSTEM
Original Applicant
EBI, L.P.
399 jefferson road
parsippany,  NJ  07054
Original Contact jonas wilf
Regulation Number888.3070
Classification Product Code
MNI  
Subsequent Product Codes
KWP   KWQ   MNH  
Date Received03/31/2000
Decision Date 04/14/2000
Decision substantially equivalent (SESE)
Regulation Medical Specialty Orthopedic
510k Review Panel Orthopedic
Type Special
Reviewed by Third Party No
Combination Product No
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