510(k) K131350 ยท MAX Intervertebral Fusion Device With Bone Graft, Lumbar
CALIX LUMBAR SPINAL IMPLANT SYSTEM
| Applicant | X-Spine Systems, Inc., Miamisburg OH, US |
| Decision | Substantially Equivalent, Oct 23, 2013 |
| Received | May 10, 2013 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K131350
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| May 17, 2016 | X Spine Systems Inc Calix P PEEK Lumbar System, PLIF Rasp Terminated |
MAX | None listed |
| May 17, 2016 | X Spine Systems Inc Calix P PEEK Lumbar System, PLIF Trial Terminated |
MAX | None listed |
| May 17, 2016 | X Spine Systems Inc Calix T PEEK Lumbar System, TLIF Rasp Terminated |
MAX | None listed |
| May 17, 2016 | X Spine Systems Inc Calix T PEEK Lumbar System, TLIF Trial Terminated |
MAX | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.