Recognized a 510(k)/PMA number — showing its clearance record and devices.
Devices
| Brand | Model | Company | Product codes | Primary DI |
|---|---|---|---|---|
| SFS;SFS LE;SFS SCOLI | 59-4625 | Orthofix US LLC | MNI | 18257200058372 |
| SFS;SFS LE;SFS SCOLI | 59-3745 | Orthofix US LLC | MNI | 18257200057962 |
| SFS;SFS LE;SFS SCOLI | 59-3445 | Orthofix US LLC | MNI | 18257200057634 |
| SFS;SFS LE;SFS SCOLI | 56-3830 | Orthofix US LLC | MNI | 18257200055968 |
| SFS | 57-2160 | Orthofix US LLC | MNI | 18257200056378 |
| SFS;SFS LE;SFS SCOLI | 59-4575 | Orthofix US LLC | MNI | 18257200058365 |
| SFS;SFS LE;SFS SCOLI | 56-3875 | Orthofix US LLC | MNI | 18257200056057 |
| SFS;SFS LE;SFS SCOLI | 56-3780 | Orthofix US LLC | MNI | 18257200055944 |
| SFS;SFS LE;SFS SCOLI | 56-3450 | Orthofix US LLC | MNI | 18257200055555 |
| SFS;SFS LE;SFS SCOLI | 56-3435 | Orthofix US LLC | MNI | 18257200055524 |
| SFS;SFS LE;SFS SCOLI | 58-3770 | Orthofix US LLC | MNI | 18257200057016 |
| SFS;SFS LE;SFS SCOLI | 59-4435 | Orthofix US LLC | MNI | 18257200058181 |
| SFS;SFS LE;SFS SCOLI | 55-4670 | Orthofix US LLC | MNI | 18257200054626 |
| SFS;SFS LE;SFS SCOLI | 59-4565 | Orthofix US LLC | MNI | 18257200058341 |
| SFS;SFS LE;SFS SCOLI | 59-4465 | Orthofix US LLC | MNI | 18257200058242 |
| SFS | 59-0300 | Orthofix US LLC | MNI | 18257200057528 |
| SFS | 55-5235 | Orthofix US LLC | MNI | 18257200055005 |
| SFS;SFS LE;SFS SCOLI | 58-3880 | Orthofix US LLC | MNI | 18257200057153 |
| SFS;SFS LE;SFS SCOLI | 56-3570 | Orthofix US LLC | MNI | 18257200055692 |
| SFS;SFS LE;SFS SCOLI | 58-3455 | Orthofix US LLC | MNI | 18257200056651 |
| SFS;SFS LE;SFS SCOLI | 56-3755 | Orthofix US LLC | MNI | 18257200055890 |
| SFS;SFS LE;SFS SCOLI | 56-3650 | Orthofix US LLC | MNI | 18257200055760 |
| SFS;SFS LE;SFS SCOLI | 59-4655 | Orthofix US LLC | MNI | 18257200058433 |
| SFS;SFS LE;SFS SCOLI | 59-3765 | Orthofix US LLC | MNI | 18257200058006 |
| SFS;SFS LE;SFS SCOLI | 58-3445 | Orthofix US LLC | MNI | 18257200056637 |