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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 K031381
Device Name UCR SPINAL SYSTEM, LAMINAR HOOKS, PEDICLE HOOKS, AND INSTRUMENTS
Applicant
SEASPINE
727 PARK BLVD.
SAN DIEGO,  CA  92101
Applicant Contact DIANA SMITH
Correspondent
SEASPINE
727 PARK BLVD.
SAN DIEGO,  CA  92101
Correspondent Contact DIANA SMITH
Regulation Number888.3070
Classification Product Code
MNI  
Subsequent Product Codes
KWP   MNH  
Date Received05/01/2003
Decision Date 07/30/2003
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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