510(k) K031154 ยท JDW Pin, Fixation, Threaded
SINTEA BIOTECH SCHANZ SCREW, MODEL TFX.SS.XX.X
| Applicant | Sintea Biotech, Inc., Miami Beach FL, US |
| Decision | Substantially Equivalent, Jun 24, 2003 |
| Received | Apr 11, 2003 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K031154
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.