510(k) K103228 ยท MAX Intervertebral Fusion Device With Bone Graft, Lumbar
PARAMOUNT R IBF DEVICE
| Applicant | Theken Spine, LLC, Akron OH, US |
| Decision | Substantially Equivalent, Jan 5, 2011 |
| Received | Nov 2, 2010 |
| Type | Special |
| FDA record | Open on fda.gov |
Recalls that name K103228
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.