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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Prosthesis, Shoulder, Hemi-, Humeral, Metallic Uncemented
510(k) Number K063578
Device Name PROMOS MODULAR SHOULDER 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 Number888.3690
Classification Product Code
HSD  
Subsequent Product Code
KWS  
Date Received11/30/2006
Decision Date 03/02/2007
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
Recalls CDRH Recalls
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