Device Classification Name |
prosthesis, knee, patellofemorotibial, semi-constrained, cemented, polymer/metal/polymer
|
510(k) Number |
K131019 |
Device Name |
ITOTAL CRUCIATE RETAINING (C) KNEE REPLACEMENT SYSTEM |
Applicant |
CONFORMIS, INC. |
28 Crosby Dr |
Bedford,
MA
01730
|
|
Applicant Contact |
AMITA SHAH |
Correspondent |
CONFORMIS, INC. |
28 Crosby Dr |
Bedford,
MA
01730
|
|
Correspondent Contact |
AMITA SHAH |
Regulation Number | 888.3560
|
Classification Product Code |
|
Subsequent Product Codes |
|
Date Received | 04/12/2013 |
Decision Date | 05/24/2013 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Orthopedic
|
510k Review Panel |
Orthopedic
|
Summary |
Summary
|
Type |
Special
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|