Panels › Orthopedic › Product code MBB · Class 2
Bone Cement, Antibiotic
Regulation 888.3027
0510(k)s in 12 months (19 all time)
2recalls in 12 months (7 all time)
6recalls that name a 510(k)
Top companies in MBB
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Sep 25, 2026 | Heraeus Medical GmbH (Dental Division) PALACOS MV+G pro 40; PALACOS MV+G pro 80. Model/Catalog Number: 5081290; 5081291.
Radiopaque, poly(methyl methacrylate)-based (PMMA) bone cement, pre-filled into a mixing and application system, suit Open, Classified |
MBB | K210607 |
| Sep 25, 2026 | Heraeus Medical GmbH (Dental Division) PALACOS R+G pro 40; PALACOS R+G pro 80. Model/Catalog Number: 5081288; 5081289.
Radiopaque, poly(methyl methacrylate)-based (PMMA) bone cement, pre-filled into a mixing and application system, suita Open, Classified |
MBB | K210607 |
| 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 | K123081 |
| Mar 5, 2015 | DePuy Orthopaedics, Inc. SMARTSET GHV Gentamicin Bone Cement. A self-curing, radiopaque, polymethyl methacrylate based cement containing antibiotic. It is used for securing a metal or polymeric prosthesis to living bone in a Terminated |
MBB | K033563 |
| 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 | K031673 |
| Oct 23, 2013 | DePuy Orthopaedics, Inc. SmartSet Endurance GMV, Gentamicin, REF 3105-040, Medium Viscosity Antibiotic Bone Cement, Sterile.
SmartSet GMV Endurance Gentamicin, bone cements are self-curing, radiopaque, polymethyl methacryla Terminated |
MBB | None listed |
| Jan 10, 2007 | Stryker Howmedica Osteonics Corp. Simplex P with Tobramycin. Antibiotic PMMA Bone Cement. Terminated |
MBB | K014199 |
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