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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Prosthesis, Hip, Hemi-, Femoral, Metal/Polymer, Cemented Or Uncemented
510(k) Number K091967
Device Name MEDACTA BIPOLAR HEAD
Applicant
Medacta International S.A.
13721 Via Tres Vista
San Diego,  CA  92129
Applicant Contact NATALIE J KENNEL
Correspondent
Medacta International S.A.
13721 Via Tres Vista
San Diego,  CA  92129
Correspondent Contact NATALIE J KENNEL
Regulation Number888.3390
Classification Product Code
KWY  
Date Received07/01/2009
Decision Date 03/02/2010
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Orthopedic
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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