510(k) K181837 ยท MAX Intervertebral Fusion Device With Bone Graft, Lumbar
Spinal Elements Ti-Bond coated devices
| Applicant | Spinal Elements, Inc., Carlsbad CA, US |
| Decision | Substantially Equivalent, Nov 2, 2018 |
| Received | Jul 10, 2018 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K181837
No recall in the FDA data names this 510(k).
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.