| Device Classification Name |
Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer/Metal/Polymer
|
|---|
| 510(k) Number |
K123339 |
|---|
| Device Name |
TK1 TOTAL KNEE SYSTEM |
|---|
| Applicant |
| Novosource, Inc. |
| 124 S. 600 W. |
|
Logan,
UT
84321
|
|
| Applicant Contact |
JAMES PINKSTON |
| Correspondent |
| Novosource, Inc. |
| 124 S. 600 W. |
|
Logan,
UT
84321
|
|
| Correspondent Contact |
JAMES PINKSTON |
| Regulation Number | 888.3560 |
|---|
| Classification Product Code |
|
|---|
| Date Received | 10/31/2012 |
|---|
| Decision Date | 04/11/2013 |
|---|
| Decision |
Substantially Equivalent
(SESE) |
|---|
| Regulation Medical Specialty |
Orthopedic
|
|---|
| 510k Review Panel |
Orthopedic
|
|---|
| Summary |
Summary
|
| Type |
Traditional
|
|---|
| Reviewed by Third Party |
No
|
|---|
| Combination Product |
No
|
|---|
Predetermined Change
Control Plan Authorized |
No
|
|---|