510(k) K031673 ยท LOD Bone Cement
REFOBACIN -PALACOS G
| Applicant | Heraeus Kulzer GmbH & Co. KG, Hanau, DE |
| Decision | Substantially Equivalent, May 25, 2004 |
| Received | May 30, 2003 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K031673
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Jan 13, 2014 | Zimmer, Inc. Palacos R+G Radioplaque Bone Cement 1 x 40 g Single (with Gentamicin), 40.8 g Methyl Acrylate Copolymer, 20 ml Methyl Methacrylate Monomer 0.5 g Gentamicin, Distributed by Zimmer Dover, OH 44522
The Terminated |
MBB | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.