510(k) K031826 ยท MQV Filler, Bone Void, Calcium Compound
TRIHA +
| Applicant | Teknimed, S.A., Round Rock TX, US |
| Decision | Substantially Equivalent, Nov 28, 2003 |
| Received | Jun 13, 2003 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K031826
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Feb 22, 2007 | Teknimed SA OsSatura TCP (pure tricalcium phosphate) 3mm granules packaged in glass jars, Part Numbers: 05-6010-050 5cc, 05-6010-100 10cc, 05-6010-150 15cc & 05-6010-300 30cc Terminated |
MQV | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.