| Device Classification Name |
appliance, fixation, spinal intervertebral body
|
|---|
| 510(K) Number |
K122497 |
|---|
| Models |
11-1106-FD1,
11-1106-FD10,
11-1106-FD11,
11-1106-FD12,
11-1106-FD13,
11-1106-FD14,
11-1106-FD15,
11-1106-FD16,
11-1106-FD17,
11-1106-FD18,
11-1106-FD19,
11-1106-FD2,
11-1106-FD20,
11-1106-FD3,
11-1106-FD4,
11-1106-FD5,
11-1106-FD6,
11-1106-FD7,
11-1106-FD8,
11-1106-FD9
|
| Device Name |
ASFORA ANTERIOR CERVICAL PLATE SYSTEM, ONE LEVEL, 14MM ASFORA ANTERIOR CERVICAL PLATE SYSTEM, ONE LEVEL, 16MM |
|---|
| Applicant |
| MEDICAL DESIGN LLC. |
| 6709 s. minnesota ave. ste 204 |
|
sioux falls,
SD
57108 2593
|
|
| Contact |
kristi vondra |
| Regulation Number | 888.3060
|
|---|
| Classification Product Code |
|
|---|
| Date Received | 08/16/2012 |
|---|
| Decision Date | 10/15/2012 |
|---|
| Decision |
substantially equivalent (SE) |
|---|
| Classification Advisory Committee |
Orthopedic
|
|---|
| Review Advisory Committee |
Orthopedic
|
|---|
| summary |
summary
|
| Type |
Traditional
|
|---|
| Reviewed by Third Party |
No
|
|---|
| Expedited Review |
No
|
|---|
| Combination Product |
No
|
|---|
|
|
