510(k) K152304 ยท MAX Intervertebral Fusion Device With Bone Graft, Lumbar
Tritanium PL Cage
| Applicant | Stryker, Allendale NJ, US |
| Decision | Substantially Equivalent, Nov 19, 2015 |
| Received | Aug 14, 2015 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K152304
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Nov 28, 2018 | Howmedica Osteonics Corp. Tritanium Posterior Lumbar (PL) cage intervertebral body fusion implant. Intended for an open, less invasive, and minimally invasive PLIF or TLIF surgical procedure. Terminated |
MAX | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.