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 |