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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
Recalls CDRH Recalls
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