Recognized a 510(k)/PMA number — showing its clearance record and devices.
Clearance record K163471
Kalitec Direct InSePtion MIS Fixation System · Kalitec Direct, LLC · decided 2017-03-16 (SESE)
Devices
| Brand | Model | Company | Product codes | Primary DI |
|---|---|---|---|---|
| Kalitec Direct InSePtion MIS Fixation System | 14-ILP-0010 | Kalitec Direct LLC | PEK | B07314ILP00100 |