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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/Ceramic/Polymer, Cemented Or Non-Porous, Uncemented
510(k) Number K070928
Device Name CERAMIC BALL HEADS, 28, 32 AND 36 MM
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 Number888.3353
Classification Product Code
LZO  
Date Received04/03/2007
Decision Date 08/01/2007
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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