510(k) K173947 ยท MAX Intervertebral Fusion Device With Bone Graft, Lumbar
Lumbar Interbody Fusion System (OLLIF)
| Applicant | Advanced Research Medical, LLC, Burnsville MN, US |
| Decision | Substantially Equivalent, Jul 25, 2018 |
| Received | Dec 27, 2017 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K173947
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Apr 29, 2024 | Advanced Research Medical, LLC ADVANCED RESEARCH MEDICAL Lumbar Interbody Fusion System (OLLIF), Flexible Curette Loop Blade, Part # 01-06-4; treatment of degenerative disc disease Completed |
MAX | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.