Device Classification Name |
prosthesis, knee, patellofemorotibial, semi-constrained, cemented, polymer/metal/polymer
|
510(k) Number |
K210695 |
Device Name |
CPM Medical Consultants Tibial Revision Knee System |
Applicant |
CPM Medical Consultants, LLC. |
1565 N. Central Expressway |
Richardson,
TX
75080
|
|
Applicant Contact |
Andy Rynearson |
Correspondent |
CPM Medical Consultants, LLC. |
1565 N. Central Expressway |
Richardson,
TX
75080
|
|
Correspondent Contact |
Andy Rynearson |
Regulation Number | 888.3560
|
Classification Product Code |
|
Date Received | 03/08/2021 |
Decision Date | 08/16/2021 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Orthopedic
|
510k Review Panel |
Orthopedic
|
Summary |
Summary
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|