510(k) K160076 · MAX Intervertebral Fusion Device With Bone Graft, Lumbar
XCage Interbody Fusion System
| Applicant | Ouroboros Medical, Inc., Fremont CA, US |
| Decision | Substantially Equivalent, Oct 13, 2016 |
| Received | Jan 14, 2016 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K160076
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Feb 27, 2018 | Integrity Implants Inc. FlareHawk Interbody Fusion System (previously XCage Interbody Fusion System) Instructions for Use (IFU's) only. Product Usage: Indicated for spinal intervertebral body fusion with autogenous bone graf Terminated |
MAX | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.