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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, Humeral (Bipolar Hemi-Shoulder) Metal/Polymer, Cemented Or Uncemented
510(k) Number K990712
Device Name OSTEONICS SOLAR SHOULDER BIPOLAR SYSTEM
Applicant
Howmedica Osteonics Corp.
59 Route 17 S.
Allendale,  NJ  07401 -1677
Applicant Contact KAREN ARIEMMA
Correspondent
Howmedica Osteonics Corp.
59 Route 17 S.
Allendale,  NJ  07401 -1677
Correspondent Contact KAREN ARIEMMA
Classification Product Code
MJT  
Date Received03/04/1999
Decision Date 07/20/1999
Decision Substantially Equivalent (SESE)
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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