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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 K101670
Device Name UNITED U2 BIPOLAR IMPLANT
Applicant
United Orthopedic Corp.
No 57, Park Ave. 2, Science Park
Hsinchu,  TW 300
Applicant Contact FANG-= YUAN HO
Correspondent
United Orthopedic Corp.
No 57, Park Ave. 2, Science Park
Hsinchu,  TW 300
Correspondent Contact FANG-= YUAN HO
Regulation Number888.3390
Classification Product Code
KWY  
Date Received06/14/2010
Decision Date 10/08/2010
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
Recalls CDRH Recalls
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