510(k) K083863 ยท MNI Orthosis, Spinal Pedicle Fixation
THEKEN ATOLL OCT SPINAL SYSTEM
| Applicant | Theken Spine, LLC, Akron OH, US |
| Decision | Substantially Equivalent, Mar 27, 2009 |
| Received | Dec 29, 2008 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K083863
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.