510(k) K231438 ยท MAX Intervertebral Fusion Device With Bone Graft, Lumbar
Calibrate PSX Interbody System, Calibrate NanoTec PSX Interbody System
| Applicant | Alphatec Spine, Inc., Carlsbad CA, US |
| Decision | Substantially Equivalent, Jul 13, 2023 |
| Received | May 17, 2023 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K231438
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.