TC-PLUS PRIMARY KNEE SYSTEM


Device Classification Name

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

510(k) Number K072858
Device Name TC-PLUS PRIMARY KNEE SYSTEM
Applicant
SMITH & NEPHEW, INC.
1450 brooks rd.
memphis, 
TN 
38116

Applicant Contact rishi sinha
Correspondent
SMITH & NEPHEW, INC.
1450 brooks rd.
memphis, 
TN 
38116

Correspodent Contact rishi sinha
Regulation Number 888.3560
Classification Product Code
JWH  
Date Received 10/05/2007
Decision Date 11/20/2007
Decision

substantially equivalent

(SESE)

Regulation Medical Specialty

Orthopedic

510k Review Panel

Orthopedic

summary

summary

Type Abbreviated
Reviewed by Third Party No

Combination Product

No