510(k) K123081 ยท LOD Bone Cement
BONOS R GENTA 1X20 MODEL 01-0228; BONOS R GENTA 2X20 MODEL 01-0229; BONOS R GENTA 1X40 MODEL 01-0217; BONOS R GENTA 2X40
| Applicant | Aap Biomaterials GmbH & Co. KG, Dieburg, DE |
| Decision | Substantially Equivalent, Mar 7, 2013 |
| Received | Oct 1, 2012 |
| Type | Abbreviated |
| FDA record | Open on fda.gov |
Recalls that name K123081
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Nov 15, 2022 | Howmedica Osteonics Corp. Simplex HV With Gentamicin CE, 10 PACK-Bone cement with Gentomycin
Catalog Number: 6193-1-010 Open, Classified |
MBB | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.