UNITED U2 XPE TOTAL KNEE SYSTEM


Device Classification Name

prosthesis, knee, patellofemorotibial, semi-constrained, cemented, polymer/metal/polymer

510(k) Number K103733
Device Name UNITED U2 XPE TOTAL KNEE SYSTEM
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

Correspodent Contact fang-yuan ho
Regulation Number 888.3560
Classification Product Code
JWH  
Date Received 12/22/2010
Decision Date 08/02/2011
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