510(k) K253420 ยท MAX Intervertebral Fusion Device With Bone Graft, Lumbar
Admiral ACP System; Explorer TO System; Laminoplasty System; Manta Ray TDF Spacer; Meridian Interbody System; Meridian Anterior Plate System; Reef L Interbody System; Reef TO/TA System; Regatta Lateral System; Regatta Lateral Plate System; Shoreline ACS Interbody System; Shoreline Threaded TruProfil
| Applicant | SeaSpine Orthopedics Corporation, Carlsbad CA, US |
| Decision | Substantially Equivalent, Jul 1, 2026 |
| Received | Oct 1, 2025 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K253420
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.