The following data is part of a premarket notification filed by Ldr Spine Usa with the FDA for Avenue L Lateral Lumbar Cage, Avenue T Tlif Cage System, Roi-a Alif Cage System, Roi-t Implant System.
| Device ID | K153495 |
| 510k Number | K153495 |
| Device Name: | Avenue L Lateral Lumbar Cage, Avenue T TLIF Cage System, ROI-A ALIF Cage System, ROI-T Implant System |
| Classification | Intervertebral Fusion Device With Bone Graft, Lumbar |
| Applicant | LDR Spine USA 13785 Research Boulevard, Suite 200 Austin, TX 78750 |
| Contact | Brad Strasser |
| Correspondent | Justin Eggleton Musculoskeletal Clinical Regulatory Advisors, LLC 1331 H Street NW, 12th Floor Washington, DC 20005 |
| Product Code | MAX |
| Subsequent Product Code | MQP |
| Subsequent Product Code | OVD |
| CFR Regulation Number | 888.3080 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2015-12-07 |
| Decision Date | 2016-03-31 |
| Summary: | summary |