The following data is part of a premarket notification filed by U&i Corp. with the FDA for Perfix Spinal System, Model Sna4530-9610, Snm4530-9610, Sn3020 (total: 549).
| Device ID | K091725 |
| 510k Number | K091725 |
| Device Name: | PERFIX SPINAL SYSTEM, MODEL SNA4530-9610, SNM4530-9610, SN3020 (TOTAL: 549) |
| Classification | Orthosis, Spondylolisthesis Spinal Fixation |
| Applicant | U&I CORP. 529-1 YONGHYUN-DONG Euijungbu, Kyunggi-do, KR 480-050 |
| Contact | Sung Youn Cho |
| Correspondent | Sung Youn Cho U&I CORP. 529-1 YONGHYUN-DONG Euijungbu, Kyunggi-do, KR 480-050 |
| Product Code | MNH |
| CFR Regulation Number | 888.3070 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2009-06-11 |
| Decision Date | 2009-11-09 |
| Summary: | summary |