510(k) K093285 ยท MNI Orthosis, Spinal Pedicle Fixation
MODIFICATION TO LANX SPINAL FIXATION SYSTEM
| Applicant | Lanx, LLC, Broomfield CO, US |
| Decision | Substantially Equivalent, Dec 10, 2009 |
| Received | Oct 20, 2009 |
| Type | Special |
| FDA record | Open on fda.gov |
Recalls that name K093285
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.