510(k) K022065 ยท JEC Component, Traction, Invasive
SINTEA BIOTECH TRAUMAFIX SYSTEM, MODEL TFX.00.00.X
| Applicant | Sintea Biotech, Inc., Miami Beach FL, US |
| Decision | Substantially Equivalent, Aug 6, 2002 |
| Received | Jun 25, 2002 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K022065
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.