510(k) K103111 ยท MAX Intervertebral Fusion Device With Bone Graft, Lumbar
FORZA SPACER SYSTEM
| Applicant | Orthofix, Inc., Lewisville TX, US |
| Decision | Substantially Equivalent, Mar 23, 2011 |
| Received | Oct 21, 2010 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K103111
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Feb 15, 2012 | Orthofix, Inc. Orthofix rotating cutter used in spinal fusion procedures with the FORZA Spacer System. Catalog Number 89-0452 (8mm Rotating Cutter), 89-0454 (10mm Rotating Cutter), and 89-0030 (FORZA Discectomy Cas Terminated |
MAX | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.