| Device Classification Name |
orthopedic stereotaxic instrument
|
|---|
| 510(K) Number |
K121936 |
|---|
| Models |
NPFS-02000 NAVIO PFS-NORTH AMERICAN (120 V),
NPFS-02010 NAVIO PFS- INTERNATIONAL (230 V)
|
| Device Name |
NAVIOPFS |
|---|
| Applicant |
| BLUE BELT TECHNOLOGIES, INC. |
| 2828 liberty avenue |
| suite 100 |
|
pittsburgh,
PA
15222
|
|
| Contact |
richard g confer |
| Regulation Number | 882.4560
|
|---|
| Classification Product Code |
|
|---|
| Date Received | 07/02/2012 |
|---|
| Decision Date | 11/30/2012 |
|---|
| Decision |
substantially equivalent (SE) |
|---|
| Classification Advisory Committee |
Orthopedic
|
|---|
| Review Advisory Committee |
General & Plastic Surgery
|
|---|
| summary |
summary
|
| Type |
Traditional
|
|---|
| Reviewed by Third Party |
No
|
|---|
| Expedited Review |
No
|
|---|
| Combination Product |
No
|
|---|
|
|
