510(k) K082679 ยท JEC Component, Traction, Invasive
LAKI HAND FIXATION SYSTEM, MODEL TFX.3X.06.X
| Applicant | Sintea Biotech, Inc., Miami Beach FL, US |
| Decision | Substantially Equivalent, Apr 7, 2009 |
| Received | Sep 15, 2008 |
| Type | Special |
| FDA record | Open on fda.gov |
Recalls that name K082679
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.