510(k) K083178 ยท MNI Orthosis, Spinal Pedicle Fixation
SOLAS ANATOMIX SPINAL SYSTEM
| Applicant | Biotechni America Spine Group, Inc., Seattle WA, US |
| Decision | Substantially Equivalent, Feb 23, 2009 |
| Received | Oct 28, 2008 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K083178
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.