UKNEE TOTAL KNEE SYSTEM


Device Classification Name

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

510(k) Number K021657
Device Name UKNEE TOTAL KNEE SYSTEM
Original Applicant
UNITED ORTHOPEDIC CORP.
57 park ave. 2, science park
hsinchu, 

TW

300

Original Contact philip leung
Regulation Number 888.3560
Classification Product Code
JWH  
Date Received 05/20/2002
Decision Date 08/12/2002
Decision

substantially equivalent

(SESE)

Regulation Medical Specialty

Orthopedic

510k Review Panel

Orthopedic

summary

summary

Type Traditional
Reviewed by Third Party No

Combination Product

No