510(k) K131547 ยท OVD Intervertebral Fusion Device With Integrated Fixation, Lumbar
LANX FUSION SYSTEM
| Applicant | Lanx, Inc., Broomfield CO, US |
| Decision | Substantially Equivalent, Jul 12, 2013 |
| Received | May 29, 2013 |
| Type | Special |
| FDA record | Open on fda.gov |
Recalls that name K131547
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Nov 26, 2013 | Lanx, Inc. LANX Timberline MPF Lateral Modular Plate Fixation System Straight Split Tip Driver - Short ("Driver"). Model Number 8630-0107.
The Timberline MPF device is an intervertebral body fusion device consi Terminated |
OVD | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.