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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 K010124
Device Name ARTHREX UNIVERS 30 SHOULDER PROSTHESIS
Applicant
Arthrex, Inc.
2885 S. Horseshoe Dr.
Naples,  FL  34104
Applicant Contact VERNON BROWN
Correspondent
Arthrex, Inc.
2885 S. Horseshoe Dr.
Naples,  FL  34104
Correspondent Contact VERNON BROWN
Regulation Number888.3660
Classification Product Code
KWS  
Subsequent Product Code
HSD  
Date Received01/16/2001
Decision Date 04/06/2001
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Orthopedic
510k Review Panel Orthopedic
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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