510(k) K141830 ยท MQV Filler, Bone Void, Calcium Compound
STIMULAN KIT, STIMULAN RAPID CURE
| Applicant | Biocomposites, Ltd., Keele, GB |
| Decision | Substantially Equivalent, Jan 23, 2015 |
| Received | Jul 7, 2014 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K141830
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Nov 12, 2020 | Biocomposites, Ltd. Stimulan Kit 10cc, Model 600-010 - Product Usage: intended for use as a bone void filler for voids or gaps that are not intrinsic to the stability of the bony structure. Terminated |
MQV | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.