CONFORMIS IUNI UNICONDYLAR KNEE REPLACEMENT SYSTEM


Device Classification Name

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

510(k) Number K111916
Device Name CONFORMIS IUNI UNICONDYLAR KNEE REPLACEMENT SYSTEM
Applicant
CONFORMIS, INC.
11 north avenue
burlington, 
MA 
01803

Applicant Contact amita s shah
Correspondent
CONFORMIS, INC.
11 north avenue
burlington, 
MA 
01803

Correspodent Contact amita s shah
Regulation Number 888.3520
Classification Product Code
HSX  
Subsequent Product Code
OOG  
Date Received 07/06/2011
Decision Date 09/29/2011
Decision

substantially equivalent

(SESE)

Regulation Medical Specialty

Orthopedic

510k Review Panel

Orthopedic

summary

summary

Type Traditional
Reviewed by Third Party No

Combination Product

No