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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
Recalls CDRH Recalls
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