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 | K173524 |
| 510k Number | K173524 |
| Device Name: | ANAX 5.5™ Spinal System |
| Classification | Thoracolumbosacral Pedicle Screw System |
| Applicant | U&I Corporation 20, Sandan-ro 76beon-gil(Rd) Uijeongbu-si, KR 11781 |
| Contact | Jee Ae Bang |
| Correspondent | Jee Ae Bang U&I Corporation 20, Sandan-ro 76beon-gil(Rd) Uijeongbu-si, KR 11781 |
| Product Code | NKB |
| CFR Regulation Number | 888.3070 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2017-11-14 |
| Decision Date | 2017-12-13 |
| Summary: | summary |