The following data is part of a premarket notification filed by U & I Corporation with the FDA for Anax™ Oct Spinal System.
Device ID | K183383 |
510k Number | K183383 |
Device Name: | ANAX™ OCT Spinal System |
Classification | Posterior Cervical Screw System |
Applicant | U & I Corporation 20, Sandan-ro 76beon-gil(Rd) Uijeongbu-si, KR 11781 |
Contact | Young Eun Lee |
Correspondent | Young Eun Lee U & I Corporation 20, Sandan-ro 76beon-gil(Rd) Uijeongbu-si, KR 11781 |
Product Code | NKG |
CFR Regulation Number | 888.3075 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Special |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 2018-12-06 |
Decision Date | 2018-12-12 |
Summary: | summary |
Mark Image Registration | Serial | Company Trademark Application Date |
---|---|
![]() ANAX 97056657 not registered Live/Pending |
Anaxdent North America LLC 2021-10-01 |
![]() ANAX 88571862 not registered Live/Pending |
Corbett & Brown Inc. 2019-08-08 |
![]() ANAX 87276522 5237188 Live/Registered |
Microtech Knives, Inc. 2016-12-21 |
![]() ANAX 86459418 4772772 Live/Registered |
ANAX Business Technologies, LLC 2014-11-19 |
![]() ANAX 79024628 3275432 Dead/Cancelled |
DOMAINE GEROVASSILIOU S.A. 2006-05-22 |
![]() ANAX 77205255 not registered Dead/Abandoned |
Archon Capital Management LLC 2007-06-13 |