510(k) K153495 ยท MAX Intervertebral Fusion Device With Bone Graft, Lumbar
Avenue L Lateral Lumbar Cage, Avenue T TLIF Cage System, ROI-A ALIF Cage System, ROI-T Implant System
| Applicant | Ldr Spine USA, Austin TX, US |
| Decision | Substantially Equivalent, Mar 31, 2016 |
| Received | Dec 7, 2015 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K153495
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Oct 5, 2016 | LDR Spine USA, Inc. ROI-A Anterior Delivery Device. Orthopedic manual surgical instrument. Model number: SI-ROIA-0023
Auxiliary instrument used in the ROI-A-ALIR cage system: Spinal intervertbral body fusion device. Terminated |
LXH | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.