| Device Classification Name |
appliance, fixation, spinal intervertebral body |
|||
|---|---|---|---|---|
| 510(k) Number | K010466 | |||
| Device Name | TETHER ACFS | |||
| Original Applicant |
|
|||
| Original Contact | robert theken | |||
| Regulation Number | 888.3060 | |||
| Classification Product Code |
|
|||
| Date Received | 02/16/2001 | |||
| Decision Date | 05/16/2001 | |||
| Decision |
substantially equivalent (SESE) |
|||
| Regulation Medical Specialty |
Orthopedic |
|||
| 510k Review Panel |
Orthopedic |
|||
| summary |
summary |
|||
| Type | Traditional | |||
| Reviewed by Third Party | No | |||
| Combination Product |
No |