510(k) K133455 ยท MAX Intervertebral Fusion Device With Bone Graft, Lumbar
CROSSFUSE II CORONAL TAPER, CROSSFUSE II HYPERLORDOTIC
| Applicant | Pioneer Surgical Technology, Inc., Marquette MI, US |
| Decision | Substantially Equivalent, Mar 27, 2014 |
| Received | Nov 12, 2013 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K133455
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Jun 26, 2015 | RTI Surgical, Inc. (dba Pioneer Surgical Technology, Inc.) Bullet-Tip PEEK VBR/IBF System, 32mm(l) 13mm(H) Implant 32-13-32 UDI (01)008464680341 08(17)191218(10)200827; T-Plus PEEK VBR/IBF System, 10mm(W) x 27mm(l) x 13mm(H) Implant, 6degree lordotic 30-T-13- Terminated |
MAX | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.