510(k) K192718 ยท MAX Intervertebral Fusion Device With Bone Graft, Lumbar
Fortilink Interbody Fusion Device (IBF) with TETRAfuse 3D Technology
| Applicant | Pioneer Surgical Technology, Inc., Dba Rti Surgical, Inc., Marquette MI, US |
| Decision | Substantially Equivalent, Dec 20, 2019 |
| Received | Sep 27, 2019 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K192718
No recall in the FDA data names this 510(k).
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.