510(k) K190498 · MAX Intervertebral Fusion Device With Bone Graft, Lumbar
Fortilink® IBF System with TETRAfuse®3D Technology, include the following designs: Fortilink®-TS IBF System, Fortilink®-L I BF System, Fortilink®-C IBF System
| Applicant | Pioneer Surgical Technology, Inc., Dba Rti Surgical, Inc., Alachua FL, US |
| Decision | Substantially Equivalent, Jul 5, 2019 |
| Received | Feb 28, 2019 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K190498
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.