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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name plate, fixation, bone
510(k) Number K141784
Device Name ORTHO SOLUTIONS ULTOS PLATING SYSTEM
Applicant
ORTHO SOLUTIONS LIMITED
3150 EAST 200TH STREET
PRIOR LAKE,  MN  55372
Applicant Contact AL LIPPINCOTT
Correspondent
ORTHO SOLUTIONS LIMITED
3150 EAST 200TH STREET
PRIOR LAKE,  MN  55372
Correspondent Contact AL LIPPINCOTT
Regulation Number888.3030
Classification Product Code
HRS  
Subsequent Product Codes
HWC   KTT  
Date Received07/02/2014
Decision Date 07/23/2014
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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