510(k) K210044 ยท MAX Intervertebral Fusion Device With Bone Graft, Lumbar
Crystal Spinal System & Vertu Spinal System, Lucent Spinal System, Zeus Spinal System, Ceres-C Spinal System, Omega XP Spinal System
| Applicant | Spinal Elements, Inc., Carlsbad CA, US |
| Decision | Substantially Equivalent, Jun 30, 2021 |
| Received | Jan 7, 2021 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K210044
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.