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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Orthosis, Spondylolisthesis Spinal Fixation
510(k) Number K031585
Device Name U&I, OPTIMA, SPINAL SYSTEM
Applicant
U&I CORP., AMERICA
6132 SOUTH 380 WEST,
MURRAY,  UT  84107 -6988
Applicant Contact PATRICK MOORE
Correspondent
U&I CORP., AMERICA
6132 SOUTH 380 WEST,
MURRAY,  UT  84107 -6988
Correspondent Contact PATRICK MOORE
Regulation Number888.3070
Classification Product Code
MNH  
Subsequent Product Codes
KWQ   MNI  
Date Received05/21/2003
Decision Date 06/27/2003
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Orthopedic
510k Review Panel Orthopedic
Summary Summary
Type Special
Reviewed by Third Party No
Combination Product No
Recalls CDRH Recalls
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