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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 K062113
Device Name SOLAR REUNION FRACTURE STEM
Applicant
HOWMEDICA OSTEONICS CORP.
325 Corporate Drive
Mahwah,  NJ  07430
Applicant Contact FRANCISCO HARO
Correspondent
HOWMEDICA OSTEONICS CORP.
325 Corporate Drive
Mahwah,  NJ  07430
Correspondent Contact FRANCISCO HARO
Regulation Number888.3660
Classification Product Code
KWS  
Subsequent Product Code
HSD  
Date Received07/24/2006
Decision Date 10/03/2006
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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