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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Appliance, Fixation, Spinal Interlaminal
510(k) Number K031595
Device Name U & I AMERICA SPINAL HOOK SYSTEM
Applicant
U&I Corp., America
6132 S. 380 W., Suite 200
Murray,  UT  84107 -6988
Applicant Contact PATRICK MOORE
Correspondent
U&I Corp., America
6132 S. 380 W., Suite 200
Murray,  UT  84107 -6988
Correspondent Contact PATRICK MOORE
Regulation Number888.3050
Classification Product Code
KWP  
Date Received05/21/2003
Decision Date 06/24/2003
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Orthopedic
510k Review Panel Orthopedic
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
Recalls CDRH Recalls
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