510(k) K072791 ยท MAX Intervertebral Fusion Device With Bone Graft, Lumbar
ORACLE SPACER, OPAL SPACER
| Applicant | Synthes Spine, West Chester PA, US |
| Decision | Substantially Equivalent, Dec 26, 2007 |
| Received | Oct 1, 2007 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K072791
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Feb 18, 2016 | Synthes (USA) Products LLC Oblique Posterior Atraumatic Lumbar (OPAL) System, Polymeric spinal fusion cage, non-sterile, OPAL Spacer 10 mm x 24 mm, 11 mm Height - Revolve
Product Usage - The OPAL Spacer is indicated for use in Terminated |
MAX | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.