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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Screw, Fixation, Bone
510(k) Number K110895
Device Name ORTHO SOLUTIONS TRAUMA IMPLANTS FOR OSTEOSYNTHESIS
Applicant
ORTHO SOLUTIONS LIMITED
3150 E. 200TH STREET
PRIOR LAKE,  MN  55372
Applicant Contact AL LIPPINCOTT
Correspondent
ORTHO SOLUTIONS LIMITED
3150 E. 200TH STREET
PRIOR LAKE,  MN  55372
Correspondent Contact AL LIPPINCOTT
Regulation Number888.3040
Classification Product Code
HWC  
Subsequent Product Codes
HTN   HTY   JDQ   JDW  
Date Received03/30/2011
Decision Date 12/19/2011
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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