510(k) K221535 ยท MAX Intervertebral Fusion Device With Bone Graft, Lumbar
Align Lumbar Interbody Fusion System
| Applicant | Acuity Surgical Devices, LLC, Irving TX, US |
| Decision | Substantially Equivalent, Jul 22, 2022 |
| Received | May 27, 2022 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K221535
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.