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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name prosthesis, knee, patello/femorotibial, semi-constrained, uncemented, porous, coated, polymer/metal/polymer
510(k) Number K150832
Device Name U2 Femoral Component, CR, Porous Coated, Additional Sizes
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 Number888.3565
Classification Product Code
MBH  
Date Received03/30/2015
Decision Date 09/25/2015
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Orthopedic
510k Review Panel Orthopedic
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
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