510(k) K080143 ยท MNI Orthosis, Spinal Pedicle Fixation
MODIFICATION TO STRYKER SPINE OASYS SYSTEM
| Applicant | Stryker Spine, Allendale NJ, US |
| Decision | Substantially Equivalent, Feb 14, 2008 |
| Received | Jan 22, 2008 |
| Type | Special |
| FDA record | Open on fda.gov |
Recalls that name K080143
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.