FDA 510(k) Applications for Medical Device Product Code "LOD"
(Bone Cement)
| FDA 510(k) Number | Applicant | Device Name | Decision Date |
| K123225 | AAP BIOMATERIALS GMBH & CO. KG | BONOS R 1X20, BONOS R 2X20, BONOS R 1X40, BONOS R 2X40, BONOS R 1X60 | 03/15/2013 |
| K123081 | AAP BIOMATERIALS GMBH & CO. KG | 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 | 03/07/2013 |
| K212729 | Biomecanica Industria e Comerciode Produtos Ortopedicos LTDA | Bone Cement-Normal Viscosity | 05/31/2022 |
| K172408 | Biomet Inc | Biomet Bone Cement R | 10/05/2017 |
| K171540 | Biomet Inc. | Refobacin Bone Cement R | 08/30/2017 |
| K091608 | BIOMET MANUFACTURING CORP. | COBALT MV BONE CEMENT | 09/17/2009 |
| K070015 | BIOMET MANUFACTURING CORP. | COBALT V RADIOPAQUE VERTEBROPLASTY BONE CEMENT | 11/30/2007 |
| K051496 | BIOMET, INC. | COBALT BONE CEMENT | 08/04/2005 |
| K051532 | BIOMET, INC. | COBALT G HV BONE CEMENT | 08/03/2005 |
| K092150 | BIOMET, INC. | COBALT MV WITH GENTAMICIN (AKA COBALT G-MV) BONE CEMENT | 10/27/2009 |
| K993836 | BIOMET, INC. | GENERATION 4 BONE CEMENT | 12/19/2001 |
| K030086 | BIOMET, INC. | PALACOS R BONE CEMENT WITH GENTAMICIN | 12/17/2003 |
| K143100 | Cossington Ltd | NP Cement HV Genta;NP Cement LV Genta;NP Cement HV System Genta;NP Cement LV System Genta | 03/05/2015 |
| K143134 | Cossington Ltd | NP Cement HV;NP Cement LV; NP Cement HV System; NP Cement LV System | 03/05/2015 |
| K021499 | DEPUY ORTHOPAEDICS, INC. | CEMVAC ULTRA PRE-PACKED WITH DEPUY 1 BONE CEMENT | 07/24/2002 |
| K023103 | DEPUY ORTHOPAEDICS, INC. | DEPUY 1 GENTAMICIN BONE CEMENT | 09/29/2003 |
| K053003 | DEPUY ORTHOPAEDICS, INC. | DEPUY CMW 1, 2 AND 3 BONE CEMENTS | 11/22/2005 |
| K041656 | DEPUY ORTHOPAEDICS, INC. | MODIFICATION TO DEPUY 1 GENTAMICIN BONE CEMENT AND SMARTSET GMV ENDURANCE GENTAMICIN BONE CEMENT | 07/01/2004 |
| K053445 | DEPUY ORTHOPAEDICS, INC. | SMARTMIX CEMVAC PRE-FILLED WITH SMARTSET HV BONE CEMENT | 01/06/2006 |
| K033563 | DEPUY ORTHOPAEDICS, INC. | SMARTSET GHV GENTAMICIN BONE CEMENT | 02/05/2004 |
| K033382 | DEPUY ORTHOPAEDICS, INC. | SMARTSET GMV ENDURANCE GENTAMICIN BONE CEMENT | 02/05/2004 |
| K023012 | DEPUY ORTHOPAEDICS, INC. | SMARTSET HV BONE CEMENT | 02/13/2003 |
| K081155 | DEPUY ORTHOPAEDICS, INC. | SMARTSET MV BONE CEMENT | 05/14/2008 |
| K033596 | EXACTECH, INC. | CEMEX GENTA BONE CEMENT; CEMEX GENTA SYSTEM BONE CEMENT | 05/10/2004 |
| K021715 | EXACTECH, INC. | CEMEX RX, CEMEX ISOPLASTIC & CEMEX XL | 06/12/2002 |
| K031430 | EXACTECH, INC. | CEMEX SYSTEM FAST | 05/22/2003 |
| K043403 | EXACTECH, INC. | CEMEX SYSTEM GENTA FAST BONE CEMENT | 12/28/2004 |
| K000943 | EXACTECH, INC. | CEMEX SYSTEM GUN APPLICATION VERSION | 02/08/2001 |
| K193061 | G21 S.r.l | G3 40 Radiopaque Bone Cement | 03/19/2020 |
| K181282 | G21 S.r.l | G3A 40 Bone Cement | 01/09/2019 |
| K193059 | G21 S.r.l. | G1 40 Radiopaque Bone Cement | 03/19/2020 |
| K173494 | G21 s.r.l. | OrthoSteady G Bone Cement | 03/06/2018 |
| K150408 | G21 S.R.L. | V-STEADY, V-FAST | 12/14/2015 |
| K050085 | HERAEUS KULZER GMBH | OSTEOPAL V | 09/14/2005 |
| K050854 | HERAEUS KULZER GMBH | PALACOS LV+G | 07/07/2005 |
| K050855 | HERAEUS KULZER GMBH | PALAMED G | 07/07/2005 |
| K030903 | HERAEUS KULZER GMBH & CO. KG | OSTEOPAL | 09/23/2003 |
| K022251 | HERAEUS KULZER GMBH & CO. KG | PALABOND | 02/26/2003 |
| K030902 | HERAEUS KULZER GMBH & CO. KG | PALACOS R | 09/23/2003 |
| K031673 | HERAEUS KULZER GMBH & CO. KG | REFOBACIN -PALACOS G | 05/25/2004 |
| K153737 | HERAEUS MEDICAL GMBH | OSTEOPAL plus | 04/22/2016 |
| K190766 | Heraeus Medical GmbH | PALACOS fast R+G | 05/31/2019 |
| K182260 | Heraeus Medical GmbH | PALACOS MV | 09/17/2018 |
| K213812 | Heraeus Medical GmbH | PALACOS MV pro | 02/02/2022 |
| K150119 | HERAEUS MEDICAL GMBH | PALACOS R pro | 06/17/2015 |
| K210607 | Heraeus Medical GmbH | PALACOS R pro, PALACOS R+G pro, PALACOS MV+G pro | 07/09/2021 |
| K202475 | Heraeus Medical GmbH | PALACOS R, PALACOS R pro, PALACOS R+G, PALACOS R+G pro, PALACOS MV+G | 11/23/2020 |
| K142157 | HERAEUS MEDICAL GMBH | PALACOS R+G PRO | 09/05/2014 |
| K030904 | Heraeus Medical Gmbh Technology | PALAMED | 09/23/2003 |
| K053198 | HOWMEDICA OSTEONICS CORP | SIMPLEX P SPEEDSET BONE CEMENT | 01/26/2006 |
| K014199 | HOWMEDICA OSTEONICS CORP. | SURGICAL SIMPLEX P WITH TOBRAMYCIN | 05/06/2003 |
| K013755 | IMMEDICA, INC. | CONCERT RADIOPAQUE BONE CEMENT | 02/08/2002 |
| K010586 | MERCK BIOMATERIAL GMBH | PALAMED BONE CEMENT | 10/30/2001 |
| K211869 | Ormed Grup Medikal Turizm Saglik Hizmetleri Sanayi Ve | OGM 1 Polymethylmethacrylate (PMMA) bone cement, OGM 1A Polymethylmethacrylate (PMMA) bone cement | 05/19/2022 |
| K210125 | OSARTIS GmbH | BonOs HV Genta, BonOs MV Genta, BonOs LV Genta | 03/19/2021 |
| K210120 | Osartis GmbH | BonOs HV, BonOs MV, BonOs LV | 03/19/2021 |
| K202458 | Osartis GmbH | BonOs Inject, Pedicle screw kits, Cement pusher | 05/18/2021 |
| K192394 | OSARTIS GmbH | Hi-Fatigue Bone Cement | 12/02/2019 |
| K192379 | OSARTIS GmbH | Hi-Fatigue G Bone Cement | 11/27/2019 |
| K033509 | SMITH & NEPHEW, INC. | MODIFICATION TO VERSABOND BONE CEMENT | 11/28/2003 |
| K022688 | SMITH & NEPHEW, INC. | VERSABOND AB BONE CEMENT | 04/29/2004 |
| K001160 | SMITH & NEPHEW, INC. | VERSABOND BONE CEMENT | 12/11/2000 |
| K032945 | STRYKER CORP. | SIMPLEX X | 05/25/2004 |
| K002652 | STRYKER CORP. | SURGICAL SIMPLEX P RADIOPAQUE BONE CEMENT AND ACM AND MIXEVACII | 01/26/2001 |
| K062553 | STRYKER ORTHOPAEDICS | SIMPLEX P BONE CEMENT | 01/08/2007 |
| K170802 | Synthes (USA) Products, LLC | TRAUMACEMÖ V+ Injectable Bone Cement | 09/28/2017 |
| K211163 | Tecres S.p.A. | Bone Cement Genta, Bone Cement HV, Bone Cement LV | 01/09/2023 |
| K092773 | TECRES SPA | CEMEX GENTA, GENTA SYSTEM AND GENTA SYSTEM FAST | 11/24/2009 |
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