510(k) K182877 ยท MAX Intervertebral Fusion Device With Bone Graft, Lumbar
HALF DOME Posterior Lumbar Interbody System
| Applicant | Astura Medical, LLC, Carlsbad CA, US |
| Decision | Substantially Equivalent, May 3, 2019 |
| Received | Oct 15, 2018 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K182877
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.