Panels › Orthopedic › Product code MNI · Class 2
Orthosis, Spinal Pedicle Fixation
Regulation 888.3070
0510(k)s in 12 months (303 all time)
1recalls in 12 months (213 all time)
212recalls that name a 510(k)
Top companies in MNI
| Company | 510(k)s | Recalls |
|---|---|---|
| Valorem Surgical LLC | 0 | 144 |
| Allez Spine, LLC | 1 | 27 |
| Medtronic Sofamor Danek | 25 | 0 |
| K2m, Inc. | 15 | 0 |
| Spine Wave, Inc. | 11 | 0 |
| Blackstone Medical, Inc. | 7 | 3 |
| Stryker Spine | 7 | 2 |
| Spinal USA | 8 | 0 |
| Spinal Solutions, LLC | 0 | 8 |
| Life Spine | 7 | 0 |
| Decided | 510(k) | Device and applicant | Code |
|---|---|---|---|
| Aug 7, 1998 | K982686 | MODIFICATION TO TOWNLEY PEDICLE SCREW PLATING SYSTEM Sofamor Danek USA,Inc. | MNI |
| Jul 13, 1998 | K982154 | MODIFICATION OF TOWNLEY PEDICLE SCREW PLATING SYSTEM Danek Medical, Inc. | MNI |
| Mar 20, 1998 | K970599 | TOWNLEY PEDICLE SCREW PLATING SYSTEM Danek Medical, Inc. | MNI |
Free CSV: newest 100 rows. Paid plans export up to 1,000 or 10,000 rows.