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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name thoracolumbosacral pedicle screw system
510(k) Number K061563
Device Name EBI ARRAY SPINAL SYSTEM
Applicant
EBI, L.P.
399 JEFFERSON ROAD
PARSIPPANY,  NJ  07054
Applicant Contact JENNIFER P HARAKAL
Correspondent
EBI, L.P.
399 JEFFERSON ROAD
PARSIPPANY,  NJ  07054
Correspondent Contact JENNIFER P HARAKAL
Regulation Number888.3070
Classification Product Code
NKB  
Subsequent Product Codes
KWP   KWQ   MNH   MNI  
Date Received06/05/2006
Decision Date 06/23/2006
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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