JOURNEY UNICONDYLAR FEMORAL IMPLANT


Device Classification Name

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

510(k) Number K073175
Device Name JOURNEY UNICONDYLAR FEMORAL IMPLANT
Applicant
SMITH & NEPHEW, INC.
1450 brooks rd.
memphis, 
TN 
38116

Applicant Contact marlon ridley
Correspondent
SMITH & NEPHEW, INC.
1450 brooks rd.
memphis, 
TN 
38116

Correspodent Contact marlon ridley
Regulation Number 888.3520
Classification Product Code
HSX  
Date Received 11/13/2007
Decision Date 12/20/2007
Decision

substantially equivalent

(SESE)

Regulation Medical Specialty

Orthopedic

510k Review Panel

Orthopedic

summary

summary

Type Abbreviated
Reviewed by Third Party No

Combination Product

No