The following data is part of a premarket notification filed by U & I Corporation with the FDA for Perfix Iliac Screw System.
| Device ID | K132218 |
| 510k Number | K132218 |
| Device Name: | PERFIX ILIAC SCREW SYSTEM |
| Classification | Orthosis, Spondylolisthesis Spinal Fixation |
| Applicant | U & I CORPORATION 20, SANDAN-RO, 76BEON-GIL (RD) Uijeongbu-si, Gyeonggi-do, KR 480-859 |
| Contact | Young-geun Kim |
| Correspondent | Young-geun Kim U & I CORPORATION 20, SANDAN-RO, 76BEON-GIL (RD) Uijeongbu-si, Gyeonggi-do, KR 480-859 |
| Product Code | MNH |
| Subsequent Product Code | KWP |
| Subsequent Product Code | MNI |
| CFR Regulation Number | 888.3070 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2013-07-17 |
| Decision Date | 2013-12-17 |
| Summary: | summary |