| Device Classification Name |
appliance, fixation, spinal interlaminal
|
|---|
| 510(K) Number |
K121725 |
|---|
| Model |
26-AND 23-SCRICS
|
| Device Name |
PIONEER POSTERIOR OCCIPITO-CERVICO-THORACIC (OCT) SYSTEM |
|---|
| Applicant |
| PIONEER SURGICAL TECHNOLOGY, INC |
| 375 river park circle |
|
marquette,
MI
49855
|
|
| Contact |
sarah mcintyre |
| Regulation Number | 888.3050
|
|---|
| Classification Product Code |
|
|---|
| Subsequent Product Codes |
|
|---|
| Date Received | 06/12/2012 |
|---|
| Decision Date | 11/07/2012 |
|---|
| 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
|
|---|
|
|
