JOURNEY II BCS KNEE SYSTEM


Device Classification Name

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

510(k) Number K111711
Device Name JOURNEY II BCS KNEE SYSTEM
Applicant
SMITH & NEPHEW, INC.
7135 goodlet farms parkway
memphis, 
TN 
38116

Applicant Contact shereen myers
Correspondent
SMITH & NEPHEW, INC.
7135 goodlet farms parkway
memphis, 
TN 
38116

Correspodent Contact shereen myers
Regulation Number 888.3560
Classification Product Code
JWH  
Date Received 06/20/2011
Decision Date 09/16/2011
Decision

substantially equivalent

(SESE)

Regulation Medical Specialty

Orthopedic

510k Review Panel

Orthopedic

summary

summary

Type Abbreviated
Reviewed by Third Party No

Combination Product

No