510(k) K081153 ยท MNH Orthosis, Spondylolisthesis Spinal Fixation
NOVEL SPINAL SYSTEM
| Applicant | Medyssey Co, Ltd., Santa Fe Springs CA, US |
| Decision | Substantially Equivalent, Jan 30, 2009 |
| Received | Apr 23, 2008 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K081153
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.