The following data is part of a premarket notification filed by U & I Corporation with the FDA for Anax 5.5 Spinal System.
| Device ID | K132101 | 
| 510k Number | K132101 | 
| Device Name: | ANAX 5.5 SPINAL 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 | 
| CFR Regulation Number | 888.3070 [🔎] | 
| Decision | Substantially Equivalent (SESE) | 
| Type | Traditional | 
| 3rd Party Reviewed | No | 
| Combination Product | No | 
| Date Received | 2013-07-08 | 
| Decision Date | 2013-11-25 | 
| Summary: | summary |