510(k) K082262 ยท MAX Intervertebral Fusion Device With Bone Graft, Lumbar
LDR SPINE ROI INTERBODY FUSION SYSTEM
| Applicant | Ldr Spine USA, Austin TX, US |
| Decision | Substantially Equivalent, Feb 2, 2009 |
| Received | Aug 8, 2008 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K082262
| 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.