Recognized a 510(k)/PMA number — showing its clearance record and devices.
Clearance record K132218
PERFIX ILIAC SCREW SYSTEM · U&I Corporation · decided 2013-12-17 (SESE)
Devices
| Brand | Model | Company | Product codes | Primary DI |
|---|---|---|---|---|
| Perfix™ Iliac Screw System | SL0201 | CG MedTech Co.,Ltd. | MNH | 08800015931427 |
| Perfix™ Iliac Screw System | SL6560 | CG MedTech Co.,Ltd. | MNH | 08800015931632 |
| Perfix™ Iliac Screw System | SL0211 | CG MedTech Co.,Ltd. | MNH | 08800015931489 |
| Perfix™ Iliac Screw System | SL8580 | CG MedTech Co.,Ltd. | MNH | 08800015931793 |
| Perfix™ Iliac Screw System | SL7560 | CG MedTech Co.,Ltd. | MNH | 08800015931700 |
| Perfix™ Iliac Screw System | SL0206 | CG MedTech Co.,Ltd. | MNH | 08800015931472 |
| Perfix™ Iliac Screw System | SL7580 | CG MedTech Co.,Ltd. | MNH | 08800015931724 |
| Perfix™ Iliac Screw System | SL0213 | CG MedTech Co.,Ltd. | MNH | 08800015931502 |
| Perfix™ Iliac Screw System | SL9590 | CG MedTech Co.,Ltd. | MNH | 08800015931878 |
| Perfix™ Iliac Screw System | SL9510 | CG MedTech Co.,Ltd. | MNH | 08800015931816 |
| Perfix™ Iliac Screw System | SL0221 | CG MedTech Co.,Ltd. | MNH | 08800015931540 |
| Perfix™ Iliac Screw System | SL9560 | CG MedTech Co.,Ltd. | MNH | 08800015931847 |
| Perfix™ Iliac Screw System | SL0100 | CG MedTech Co.,Ltd. | MNH | 08800015931410 |
| Perfix™ Iliac Screw System | SL8510 | CG MedTech Co.,Ltd. | MNH | 08800015931748 |
| Perfix™ Iliac Screw System | SL7510 | CG MedTech Co.,Ltd. | MNH | 08800015931670 |
| Perfix™ Iliac Screw System | SL6550 | CG MedTech Co.,Ltd. | MNH | 08800015931625 |
| Perfix™ Iliac Screw System | SL0215 | CG MedTech Co.,Ltd. | MNH | 08800015931526 |
| Perfix™ Iliac Screw System | SL9570 | CG MedTech Co.,Ltd. | MNH | 08800015931854 |
| Perfix™ Iliac Screw System | SL0216 | CG MedTech Co.,Ltd. | MNH | 08800015931533 |
| Perfix™ Iliac Screw System | SL0225 | CG MedTech Co.,Ltd. | MNH | 08800015931588 |
| Perfix™ Iliac Screw System | SL0224 | CG MedTech Co.,Ltd. | MNH | 08800015931571 |
| Perfix™ Iliac Screw System | SL0214 | CG MedTech Co.,Ltd. | MNH | 08800015931519 |
| Perfix™ Iliac Screw System | SL6580 | CG MedTech Co.,Ltd. | MNH | 08800015931656 |
| Perfix™ Iliac Screw System | SL7590 | CG MedTech Co.,Ltd. | MNH | 08800015931731 |
| Perfix™ Iliac Screw System | SL0204 | CG MedTech Co.,Ltd. | MNH | 08800015931458 |