Device Classification Name |
Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer/Metal/Polymer
|
510(k) Number |
K142404 |
Device Name |
iTotal Posterior Stabilized (PS) 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 |
|
Date Received | 08/27/2014 |
Decision Date | 12/11/2014 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Orthopedic
|
510k Review Panel |
Orthopedic
|
Summary |
Summary
|
Type |
Special
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
Recalls |
CDRH Recalls
|
|
|