510(k) K102738 ยท OVD Intervertebral Fusion Device With Integrated Fixation, Lumbar
LANX FUSION SYSTEM
| Applicant | Lanx, LLC, Broomfield CO, US |
| Decision | Substantially Equivalent, Feb 10, 2011 |
| Received | Sep 22, 2010 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K102738
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Dec 16, 2014 | Biomet Spine LLC. LANX, REF, PCR8XXX-XXX, LOT, RXONLY. Packaged within aluminum sterilization case.
Product Usage:
The Durango implant is intended for spinal fusion procedures to be used with autogenous bone graft in Terminated |
MAX | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.