MODIFICATION TO JOURNEY UNICONDYLAR FEMORAL IMPLANT


Device Classification Name

prosthesis, knee, femorotibial, non-constrained, cemented, metal/polymer

510(k) Number K081351
Device Name MODIFICATION TO JOURNEY UNICONDYLAR FEMORAL IMPLANT
Applicant
SMITH & NEPHEW, INC.
1450 e brooks road
memphis, 
TN 
38116

Applicant Contact nicholas b tabrizi
Correspondent
SMITH & NEPHEW, INC.
1450 e brooks road
memphis, 
TN 
38116

Correspodent Contact nicholas b tabrizi
Regulation Number 888.3520
Classification Product Code
HSX  
Date Received 05/14/2008
Decision Date 07/24/2008
Decision

substantially equivalent

(SESE)

Regulation Medical Specialty

Orthopedic

510k Review Panel

Orthopedic

summary

summary

Type Special
Reviewed by Third Party No

Combination Product

No