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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, metal/polymer, porous uncemented
510(k) Number K122504
Device Name FEMORAL HEADS, 2.5 AND 7.5 MM NECK LENGTH
Applicant
UNITED ORTHOPEDIC CORPORATION
NO 57, PARK AVE 2,
SCIENCE PARK
HSINCHU,  TW 300
Applicant Contact FANG-YUAN HO
Correspondent
UNITED ORTHOPEDIC CORPORATION
NO 57, PARK AVE 2,
SCIENCE PARK
HSINCHU,  TW 300
Correspondent Contact FANG-YUAN HO
Regulation Number888.3358
Classification Product Code
LPH  
Date Received08/16/2012
Decision Date 10/10/2012
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Orthopedic
510k Review Panel Orthopedic
Summary Summary
Type Special
Reviewed by Third Party No
Combination Product No
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