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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 K043232
Device Name UCR SPINAL SYSTEM
Applicant
SEASPINE
2303 LA MIRADA DRIVE
VISTA,  CA  92081 -7862
Applicant Contact DIANA SMITH
Correspondent
SEASPINE
2303 LA MIRADA DRIVE
VISTA,  CA  92081 -7862
Correspondent Contact DIANA SMITH
Regulation Number888.3070
Classification Product Code
NKB  
Subsequent Product Codes
KWP   MNH   MNI  
Date Received11/22/2004
Decision Date 12/21/2004
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Orthopedic
510k Review Panel Orthopedic
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Recalls CDRH Recalls
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