Device Classification Name |
Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer/Metal/Polymer
|
510(k) Number |
K221939 |
Device Name |
Cemented Round Patella with JRNY Pegs |
Applicant |
Smith & Nephew, Inc. |
7135 Goodlett Farms Parkway |
Cordova,
TN
38016
|
|
Applicant Contact |
Madison Padgett |
Correspondent |
Smith & Nephew, Inc. |
7135 Goodlett Farms Parkway |
Cordova,
TN
38016
|
|
Correspondent Contact |
Madison Padgett |
Regulation Number | 888.3560
|
Classification Product Code |
|
Date Received | 07/01/2022 |
Decision Date | 07/26/2022 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Orthopedic
|
510k Review Panel |
Orthopedic
|
Summary |
Summary
|
Type |
Special
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|