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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 K163489
Device Name OrthoSolutions 'System26' Bone Screws
Applicant
Ortho Solutions UK Limited
West Station Business Park, Spital Rd.
Maldon,  GB CM9 6FF
Applicant Contact Craig Bluett
Correspondent
Engineering Consulting Services, Inc.
3150 E. 200th. St.
Prior Lake,  MN  55372
Correspondent Contact Al Lippincott
Regulation Number888.3040
Classification Product Code
HWC  
Subsequent Product Code
HTN  
Date Received12/12/2016
Decision Date 03/08/2017
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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