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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Porous Uncemented
510(k) Number K070278
Device Name POLARCUP DUAL MOBILITY SYSTEM
Applicant
Plus Orthopedics AG
18 Bridie Lane
Norfolk,  MA  02056
Applicant Contact PAMELA J WEAGRAFF
Correspondent
Plus Orthopedics AG
18 Bridie Lane
Norfolk,  MA  02056
Correspondent Contact PAMELA J WEAGRAFF
Regulation Number888.3358
Classification Product Code
LPH  
Subsequent Product Code
KWY  
Date Received01/29/2007
Decision Date 04/16/2007
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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