CONFORMIS TOTAL KNEE REPIAR SYSTEM (ITOTAL) TIBIAL COMPONENT: 6.0 MM THICKNESS


Device Classification Name

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

510(k) Number K080936
Device Name CONFORMIS TOTAL KNEE REPIAR SYSTEM (ITOTAL) TIBIAL COMPONENT: 6.0 MM THICKNESS
Applicant
CONFORMIS, INC.
2 fourth avenue
burlington, 
MA 
01803

Applicant Contact s. michael sharp
Correspondent
CONFORMIS, INC.
2 fourth avenue
burlington, 
MA 
01803

Correspodent Contact s. michael sharp
Regulation Number 888.3560
Classification Product Code
JWH  
Date Received 04/02/2008
Decision Date 05/12/2008
Decision

substantially equivalent

(SESE)

Regulation Medical Specialty

Orthopedic

510k Review Panel

Orthopedic

summary

summary

Type Traditional
Reviewed by Third Party No

Combination Product

No