510(k) K192132 ยท MAX Intervertebral Fusion Device With Bone Graft, Lumbar
SeaSpine Beachside System
| Applicant | SeaSpine Orthopedics Corporation, Carlsbad CA, US |
| Decision | Substantially Equivalent, Dec 3, 2019 |
| Received | Aug 7, 2019 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K192132
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Sep 11, 2025 | SEASPINE ORTHOPEDICS CORPORATION Reef TA Inserter, Part Number: TA2-001003, part of the Reef Interbody System Open, Classified |
MAX | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.