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 |