510(k) K240830 ยท MAX Intervertebral Fusion Device With Bone Graft, Lumbar
Reef TO/TA System; Regatta Lateral System; Explorer TO System; WaveForm C Interbody System; WaveForm TO Interbody System; WaveForm TA Interbody System; FORZA XP Expandable Spacer System; Shoreline ACS Interbody System; Shoreline RT Interbody System; Meridian Interbody System; WaveForm A Interbody Sy
| Applicant | Orthofix Medical, Inc., Lewisville TX, US |
| Decision | Substantially Equivalent, Jun 20, 2024 |
| Received | Mar 26, 2024 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K240830
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.