| Device Classification Name |
Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer/Metal/Polymer
|
| 510(k) Number |
K901457 |
| Device Name |
CONTINUUM KNEE SYSTEM (CKS) |
| Applicant |
| Techmedica, Inc. |
| 1380 Flynn Rd. |
|
Camarillo,
CA
93010
|
|
| Applicant Contact |
DAVE MARTINEZ |
| Correspondent |
| Techmedica, Inc. |
| 1380 Flynn Rd. |
|
Camarillo,
CA
93010
|
|
| Correspondent Contact |
DAVE MARTINEZ |
| Regulation Number | 888.3560 |
| Classification Product Code |
|
| Date Received | 03/28/1990 |
| Decision Date | 06/20/1990 |
| Decision |
SUBSTANTIALLY EQUIVALENT FOR SOME INDICATIONS
(SN) |
| Regulation Medical Specialty |
Orthopedic
|
| 510k Review Panel |
Orthopedic
|
| Type |
Traditional
|
| Reviewed by Third Party |
No
|
| Combination Product |
No
|
Predetermined Change Control Plan Authorized |
No
|
|
|