The following data is part of a premarket notification filed by U & I Corporation with the FDA for Benefix Interspinous Fixation System.
| Device ID | K143631 |
| 510k Number | K143631 |
| Device Name: | Benefix Interspinous Fixation System |
| Classification | Spinous Process Plate |
| Applicant | U & I Corporation 20, Sandan-ro 76beon-gil/(Rd) Uijeongbu-si, KR 480-859 |
| Contact | Young-geun Kim |
| Correspondent | Young-geun Kim U & I Corporation 20, Sandan-ro 76beon-gil (Road) Uijeongbu-si, KR 480-859 |
| Product Code | PEK |
| CFR Regulation Number | 888.3050 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2014-12-22 |
| Decision Date | 2015-09-03 |
| Summary: | summary |