EVOLIS TOTAL KNEE SYSTEM


Device Classification Name

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

510(k) Number K081023
Device Name EVOLIS TOTAL KNEE SYSTEM
Applicant
MEDACTA INTERNATIONAL, SA
13721 via tres vista
san diego, 
CA 
92129

Applicant Contact natalie j kennel
Correspondent
MEDACTA INTERNATIONAL, SA
13721 via tres vista
san diego, 
CA 
92129

Correspodent Contact natalie j kennel
Regulation Number 888.3560
Classification Product Code
JWH  
Date Received 04/10/2008
Decision Date 10/22/2008
Decision

substantially equivalent

(SESE)

Regulation Medical Specialty

Orthopedic

510k Review Panel

Orthopedic

summary

summary

Type Traditional
Reviewed by Third Party No

Combination Product

No

Recalls CDRH Recalls