Device Classification Name |
Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer/Metal/Polymer
|
510(k) Number |
K193540 |
Device Name |
TRUMATCH Personalized Solutions |
Applicant |
DePuy Orthopaedics, Inc. |
700 Orthopaedic Dr. |
WARSAW,
IN
46582
|
|
Applicant Contact |
Erin Combs |
Correspondent |
DePuy Orthopaedics, Inc. |
700 Orthopaedic Dr. |
Warsaw,
IN
46582
|
|
Correspondent Contact |
Melissa Cook |
Regulation Number | 888.3560
|
Classification Product Code |
|
Subsequent Product Code |
|
Date Received | 12/20/2019 |
Decision Date | 06/16/2020 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Orthopedic
|
510k Review Panel |
Orthopedic
|
Summary |
Summary
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|