Device Classification Name |
Prosthesis, Knee, Femorotibial, Non-Constrained, Cemented, Metal/Polymer
|
510(k) Number |
K121974 |
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
|
|
Correspondent Contact |
AMITA S SHAH |
Regulation Number | 888.3520
|
Classification Product Code |
|
Date Received | 07/05/2012 |
Decision Date | 09/06/2012 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Orthopedic
|
510k Review Panel |
Orthopedic
|
Summary |
Summary
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|