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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, Semi-Constrained, Metal/Polymer Cemented
510(k) Number K030259
Device Name AMATOMICAL SHOULDER WITH REMOVABLE HEAD
Applicant
CENTERPLUS ORTHOPEDICS, INC
9900 SPECTRUM DR.
AUSTIN,  TX  78717
Applicant Contact AUDREY SWEARINGEN
Correspondent
CENTERPLUS ORTHOPEDICS, INC
9900 SPECTRUM DR.
AUSTIN,  TX  78717
Correspondent Contact AUDREY SWEARINGEN
Regulation Number888.3660
Classification Product Code
KWS  
Subsequent Product Code
HSD  
Date Received01/24/2003
Decision Date 04/24/2003
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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