The following data is part of a premarket notification filed by U&i Corporation with the FDA for Cbt Screw Fixation System.
Device ID | K181824 |
510k Number | K181824 |
Device Name: | CBT Screw Fixation 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 | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 2018-07-09 |
Decision Date | 2018-12-13 |
Summary: | summary |