CONFORMIS UNI-CONDYLAR KNEE SYSTEM


Device Classification Name

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

510(k) Number K072586
Device Name CONFORMIS UNI-CONDYLAR KNEE SYSTEM
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 888.3520
Classification Product Code
HSX  
Date Received 09/13/2007
Decision Date 11/08/2007
Decision

substantially equivalent

(SESE)

Regulation Medical Specialty

Orthopedic

510k Review Panel

Orthopedic

summary

summary

Type Traditional
Reviewed by Third Party No

Combination Product

No