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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, semi-constrained, uncemented, metal / polymer, non-porous, calcium phosphate
510(k) Number K103497
Device Name CERAMIC FEMORAL HEAD
Applicant
UNITED ORTHOPEDIC CORP.
57 PARK AVE. 2, SCIENCE PARK
HSINCHU,  TW 300
Applicant Contact FANG-YUAN HO
Correspondent
UNITED ORTHOPEDIC CORP.
57 PARK AVE. 2, SCIENCE PARK
HSINCHU,  TW 300
Correspondent Contact FANG-YUAN HO
Regulation Number888.3353
Classification Product Code
MEH  
Subsequent Product Codes
LPH   LWJ  
Date Received11/29/2010
Decision Date 03/04/2011
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Orthopedic
510k Review Panel Orthopedic
Type Traditional
Reviewed by Third Party No
Combination Product No
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