510(k) K180078 ยท MAX Intervertebral Fusion Device With Bone Graft, Lumbar
Px PEEK IBF System, Px HA PEEK IBF System, TxHA PEEK IBF System
| Applicant | Innovasis, Inc., Salt Lake City UT, US |
| Decision | Substantially Equivalent, Apr 17, 2018 |
| Received | Jan 10, 2018 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K180078
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Sep 17, 2024 | Innovasis, Inc TxHA PEEK IBF/TxTiHA IBF System REF BTA-151
i. TxHA The Innovasis TxHA PEEK IBF System is an intervertebral body fusion device intended to stabilize a spinal segment to promote fusion using bone gr Open, Classified |
MAX | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.