UNICONDYLAR FEMORAL COMPONENT


Device Classification Name

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

510(k) Number K030301
Device Name UNICONDYLAR FEMORAL COMPONENT
Original Applicant
SMITH & NEPHEW, INC.
1450 brooks rd.
memphis, 
TN 
38116

Original Contact kim kelly
Regulation Number 888.3560
Classification Product Code
JWH  
Date Received 01/29/2003
Decision Date 02/25/2003
Decision

substantially equivalent

(SESE)

Regulation Medical Specialty

Orthopedic

510k Review Panel

Orthopedic

summary

summary

Type Special
Reviewed by Third Party No

Combination Product

No