Recognized a 510(k)/PMA number — showing its clearance record and devices.
Clearance record K230623
KITE Distal Fibula Kit · Intrauma S.P.A · decided 2023-09-01 (SESE)
Devices
| Brand | Model | Company | Product codes | Primary DI |
|---|---|---|---|---|
| SYNDESMOSIS SCREW | 120.2940 | INTRAUMA SPA | HWC | 08056693002656 |
| LOCKING SCREW | 120.2516 | INTRAUMA SPA | HWC | 08056693002298 |
| KITE | KM2.7114 | INTRAUMA SPA | HRS | 08056693002076 |
| SYNDESMOSIS SCREW | 120.2958 | INTRAUMA SPA | HWC | 08056693002748 |
| LOCKING SCREW | 120.2508 | INTRAUMA SPA | HWC | 08056693002250 |
| CORTICAL SCREW | 120.2712 | INTRAUMA SPA | HWC | 08056693002458 |
| LOCKING SCREW | 120.2510 | INTRAUMA SPA | HWC | 08056693002267 |
| LOCKING SCREW | 120.2522 | INTRAUMA SPA | HWC | 08056693002328 |
| CORTICAL SCREW | 120.2714 | INTRAUMA SPA | HWC | 08056693002465 |
| SYNDESMOSIS SCREW | 120.2936 | INTRAUMA SPA | HWC | 08056693002632 |
| CORTICAL SCREW | 120.2722 | INTRAUMA SPA | HWC | 08056693002502 |
| LOCKING SCREW | 120.2546 | INTRAUMA SPA | HWC | 08056693002403 |
| CORTICAL SCREW | 120.2734 | INTRAUMA SPA | HWC | 08056693002564 |
| KITE | 120.7110 | INTRAUMA SPA | HRS | 08056693036255 |
| KITE | 120.7109 | INTRAUMA SPA | HRS | 08056693036248 |
| CORTICAL SCREW | 120.2720 | INTRAUMA SPA | HWC | 08056693002496 |
| SYNDESMOSIS SCREW | 120.2938 | INTRAUMA SPA | HWC | 08056693002649 |
| LOCKING SCREW | 120.2514 | INTRAUMA SPA | HWC | 08056693002281 |
| LOCKING SCREW | 120.2520 | INTRAUMA SPA | HWC | 08056693002311 |
| KITE | KM2.7111 | INTRAUMA SPA | HRS | 08056693002045 |
| CORTICAL SCREW | 120.2724 | INTRAUMA SPA | HWC | 08056693002519 |
| LOCKING SCREW | 120.2534 | INTRAUMA SPA | HWC | 08056693002373 |
| CORTICAL SCREW | 120.2726 | INTRAUMA SPA | HWC | 08056693002526 |
| CORTICAL SCREW | 120.2716 | INTRAUMA SPA | HWC | 08056693002472 |
| KITE | KM2.7113 | INTRAUMA SPA | HRS | 08056693002069 |