510(k) K170119 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, Sep 29, 2017 |
| Received | Jan 13, 2017 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K170119
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Dec 19, 2018 | XTANT MEDICAL INC Calix Lumbar Spinal Implant System:
22mm x 10mm x 7mm PLIF ASSY PC, REF X034-0172PC
22mm x 10mm x 8mm PLIF ASSY PC, REF X034-0173PC
26mm x 10mm x 6mm PLIF ASSY PC, REF X034-0240PC
26mm x 10mm x 8mm PL Terminated |
MAX | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.