| Device |
intraoperative orthopedic joint assessment aid |
| Regulation Description |
Stereotaxic instrument. |
| Definition |
Measurement and interpretation of orthopedic joint information. |
| Product Code | ONN |
| Regulation Number |
882.4560
|
| Device Class |
2
|
| Recalls |
| |
2007 |
2008 |
2009 |
2010 |
2011 |
2012 |
2013 |
| Class I |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
| Class II |
0 |
0 |
0 |
0 |
0 |
1 |
0 |
| Class III |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
|
| Recalls |
| Manufacturer |
Recall Class |
Date Posted |
| 1 |
Orthosensor |
II |
Oct-24-2012 |
|
|
|