Recognized a 510(k)/PMA number — showing its clearance record and devices.
Clearance record K170146
Galaxy UNYCO System · Orthofix Srl · decided 2017-10-12 (SESE)
Devices
| Brand | Model | Company | Product codes | Primary DI |
|---|---|---|---|---|
| Galaxy UNYCO System | 1 | ORTHOFIX SRL | KTT | 18054242515180 |
| Galaxy UNYCO System | 1 | ORTHOFIX SRL | KTT | 18054242515173 |