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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 K070963
Device Name REUNION HA FRACTURE STEM
Applicant
Howmedica Osteonics Corp.
325 Corporate Dr.
Malwah,  NJ  07430
Applicant Contact FRANCISCO HARO
Correspondent
Howmedica Osteonics Corp.
325 Corporate Dr.
Malwah,  NJ  07430
Correspondent Contact FRANCISCO HARO
Regulation Number888.3690
Classification Product Code
HSD  
Date Received04/05/2007
Decision Date 05/04/2007
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Orthopedic
510k Review Panel Orthopedic
Summary Summary
Type Special
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
Recalls CDRH Recalls
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