510(k) K171519 · MAX Intervertebral Fusion Device With Bone Graft, Lumbar
FLXfit
| Applicant | Expanding Orthopedics, Inc., Atlanta GA, US |
| Decision | Substantially Equivalent, Sep 15, 2017 |
| Received | May 24, 2017 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K171519
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Jan 12, 2023 | CoreLink LLC CoreLink LLC, FLXFIT 15, 32MM X 8MM, CAGE, REF: AT3208 Terminated |
MAX | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.