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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 K083089
Device Name NEWPORT SPINAL SYSTEM
Applicant
SEASPINE, INC.
2302 LA MIRADA DR.
VISTA,  CA  92081 -7862
Applicant Contact ETHEL BERNAL
Correspondent
SEASPINE, INC.
2302 LA MIRADA DR.
VISTA,  CA  92081 -7862
Correspondent Contact ETHEL BERNAL
Regulation Number888.3070
Classification Product Code
NKB  
Subsequent Product Codes
MNH   MNI  
Date Received10/16/2008
Decision Date 01/13/2009
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Orthopedic
510k Review Panel Orthopedic
Type Traditional
Reviewed by Third Party No
Combination Product No
Recalls CDRH Recalls
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