The following data is part of a premarket notification filed by U&i Corporation with the FDA for Velofix™ Tlif Cage.
Device ID | K172419 |
510k Number | K172419 |
Device Name: | Velofix™ TLIF Cage |
Classification | Intervertebral Fusion Device With Bone Graft, Lumbar |
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 | MAX |
CFR Regulation Number | 888.3080 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 2017-08-10 |
Decision Date | 2017-12-04 |
Summary: | summary |
Mark Image Registration | Serial | Company Trademark Application Date |
---|---|
![]() VELOFIX 86151986 4788231 Live/Registered |
Velofix Holdings Ltd. 2013-12-24 |
![]() VELOFIX 85885268 4827448 Live/Registered |
Velofix Holdings Ltd. 2013-03-25 |