Device Classification Name |
Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer/Metal/Polymer
|
510(k) Number |
K160025 |
Device Name |
iTotal Posterior Stabilized (PS) Knee Replacement System, iTotal Cruciate Retaining (CR) 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 | 01/06/2016 |
Decision Date | 03/07/2016 |
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
|
|
|