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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 K061677
Device Name SOLAR PUREFIX HA SHOULDER
Applicant
HOWMEDICA OSTEONICS CORP
325 CORPORATE DR.
MAHWAH,  NJ  07430
Applicant Contact TIFFANI ROGERS
Correspondent
HOWMEDICA OSTEONICS CORP
325 CORPORATE DR.
MAHWAH,  NJ  07430
Correspondent Contact TIFFANI ROGERS
Regulation Number888.3690
Classification Product Code
HSD  
Subsequent Product Code
KWS  
Date Received06/15/2006
Decision Date 07/10/2006
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Orthopedic
510k Review Panel Orthopedic
Summary Summary
Type Special
Reviewed by Third Party No
Combination Product No
Recalls CDRH Recalls
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