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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 S. 380 W.,
Murray,  UT  84107 -6988
Applicant Contact PATRICK MOORE
Correspondent
U&I Corp., America
6132 S. 380 W.,
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
Predetermined Change
Control Plan Authorized		 No
Recalls CDRH Recalls
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