510(k) K081631 ยท MNH Orthosis, Spondylolisthesis Spinal Fixation
SINTEA BIOTECH PLS MULTI-AXIAL SCREWS
| Applicant | Sintea Biotech, Inc., Miami Beach FL, US |
| Decision | Substantially Equivalent, Jul 18, 2008 |
| Received | Jun 11, 2008 |
| Type | Special |
| FDA record | Open on fda.gov |
Recalls that name K081631
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.