The following data is part of a premarket notification filed by Ldr Spine Usa Inc. with the FDA for Avenue T Tlif Cage.
| Device ID | K142645 |
| 510k Number | K142645 |
| Device Name: | Avenue T TLIF Cage |
| Classification | Intervertebral Fusion Device With Integrated Fixation, Lumbar |
| Applicant | LDR SPINE USA INC. 13785 RESEARCH BOULEVARD SUITE 200 Austin, TX 78750 |
| Contact | Bradley W. Strasser |
| Correspondent | Bradley W. Strasser LDR SPINE USA INC. 13785 RESEARCH BOULEVARD SUITE 200 Austin, TX 78750 |
| Product Code | OVD |
| CFR Regulation Number | 888.3080 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2014-09-17 |
| Decision Date | 2015-06-11 |
| Summary: | summary |