| Device Classification Name |
Prosthesis, Hip, Semi-Constrained, Uncemented, Metal / Polymer, Non-Porous, Calcium Phosphate
|
| 510(k) Number |
K932017 |
| Device Name |
TECHMEDICA CONTINUUM HIP WITH HA COATING |
| Applicant |
| Techmedica, Inc. |
| 3760 Calle Tecate |
|
Camarillo,
CA
93012
|
|
| Applicant Contact |
DAVE SAMSON |
| Correspondent |
| Techmedica, Inc. |
| 3760 Calle Tecate |
|
Camarillo,
CA
93012
|
|
| Correspondent Contact |
DAVE SAMSON |
| Regulation Number | 888.3353 |
| Classification Product Code |
|
| Date Received | 04/26/1993 |
| Decision Date | 09/01/1994 |
| Decision |
Substantially Equivalent
(SESE) |
| Regulation Medical Specialty |
Orthopedic
|
| 510k Review Panel |
Orthopedic
|
| Type |
Traditional
|
| Reviewed by Third Party |
No
|
| Combination Product |
No
|
Predetermined Change Control Plan Authorized |
No
|
|
|