Panels › Orthopedic › Product code PML · Class 2
Bone Cement, Posterior Screw Augmentation
Regulation 888.3027
2510(k)s in 12 months (19 all time)
0recalls in 12 months (2 all time)
2recalls that name a 510(k)
Top companies in PML
| Company | 510(k)s | Recalls |
|---|---|---|
| Icotec AG | 2 | 2 |
| Medtronic | 2 | 0 |
| Medtronic Sofamor Danek USA, Inc. | 2 | 0 |
| Neo Medical SA | 2 | 0 |
| Alphatec Spine, Inc. | 1 | 0 |
| Astura Medical | 1 | 0 |
| CarboFix Orthopedics , Ltd. | 1 | 0 |
| Globus Medical, Inc. | 1 | 0 |
| Medacta International S.A. | 1 | 0 |
| Medos International Sàrl | 1 | 0 |
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Jan 10, 2024 | Icotec Ag VADER pedicle system, torque wrench, Catalog Number 42-703 Open, Classified |
PML | K222789 |
| Jan 10, 2024 | Icotec Ag VADER pedicle system, torque wrench, Catalog Number 42-702 Open, Classified |
PML | K222789 |
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