510(k) K110632 ยท MAX Intervertebral Fusion Device With Bone Graft, Lumbar
LUCENT OR LUCENT MAGNUM
| Applicant | Spinal Elements, Inc., Carlsbad CA, US |
| Decision | Substantially Equivalent, May 23, 2012 |
| Received | Mar 4, 2011 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K110632
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Jan 5, 2015 | Spinal Elements, Inc Ti-Bond Marketing Literature/Labeling, Catalog No. LT10000, MP-14000
This device is intended to be used with autogenous bone graft. Patients must have undergone a regimen of at least six (6) months no Terminated |
MAX | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.