510(k) K090064 ยท MAX Intervertebral Fusion Device With Bone Graft, Lumbar
EMINENT SPINE INTERBODY FUSION SYSTEM
| Applicant | Eminent Spine, Leander TX, US |
| Decision | Substantially Equivalent, Apr 9, 2009 |
| Received | Jan 9, 2009 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K090064
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| May 27, 2013 | Spinal Solutions, LLC Copperhead IBFD, Large Neutral, 6mm
Copperhead IBFD, Large Neutral, 7mm
Copperhead IBFD, Large Neutral, 8mm
Copperhead IBFD, Large Neutral, 9mm
Copperhead IBFD, Large Neutral, 10mm
Copperhead IBF Terminated |
MAX | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.