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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 K120360
Device Name ORTHO SOLUTIONS TRAUMA PLATES FOR OSTEOSYSNTHESIS
Applicant
Ortho Solutions Limited
3150 E. 200th. St.
Prior Lake,  MN  55372
Applicant Contact AL LIPPINCOTT
Correspondent
Ortho Solutions Limited
3150 E. 200th. St.
Prior Lake,  MN  55372
Correspondent Contact AL LIPPINCOTT
Regulation Number888.3030
Classification Product Code
HRS  
Subsequent Product Codes
HTN   HWC   KTT  
Date Received02/06/2012
Decision Date 05/29/2012
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
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