FDA Product Code
FDA Product Code LOD — Clearance Directory
- Device Class
- Class II
- Assigned Panel
- Orthopedic
- 21 CFR Citation
- 888.3027
510(k) Clearances — 72 records
| K-Number | Device Name | Applicant | Decision Date | Clearance Type | Summary |
|---|---|---|---|---|---|
| K254107 | Refobacin Bone Cement R (110034355) | Biomet France | 2026-04-15 | Traditional | PDF ↗ |
| K250760 | SPECTRUM GV Bone Cement | Osteoremedies, LLC | 2025-04-02 | Special | PDF ↗ |
| K241674 | OSTEOPAL® V | Heraeus Medical GmbH | 2024-12-05 | Traditional | PDF ↗ |
| K231556 | SPECTRUM® GV Bone Cement | Osteoremedies, LLC | 2023-12-20 | Traditional | PDF ↗ |
| K211163 | Bone Cement Genta, Bone Cement HV, Bone Cement LV | Tecres S.P.A. | 2023-01-09 | Traditional | PDF ↗ |
| K212729 | Bone Cement-Normal Viscosity | Biomecanica Industria E Comerciode Produtos Ortopedicos Ltda | 2022-05-31 | Traditional | PDF ↗ |
| K211869 | OGM 1 Polymethylmethacrylate (PMMA) bone cement, OGM 1A Polymethylmethacrylate (PMMA) bone cement | Ormed Grup Medikal Turizm Saglik Hizmetleri Sanayi VE | 2022-05-19 | Traditional | PDF ↗ |
| K213812 | PALACOS MV pro | Heraeus Medical GmbH | 2022-02-02 | Traditional | PDF ↗ |
| K210607 | PALACOS R pro, PALACOS R+G pro, PALACOS MV+G pro | Heraeus Medical GmbH | 2021-07-09 | Traditional | PDF ↗ |
| K202458 | BonOs Inject, Pedicle screw kits, Cement pusher | Osartis GmbH | 2021-05-18 | Traditional | PDF ↗ |
| K210125 | BonOs HV Genta, BonOs MV Genta, BonOs LV Genta | Osartis GmbH | 2021-03-19 | Traditional | PDF ↗ |
| K210120 | BonOs HV, BonOs MV, BonOs LV | Osartis GmbH | 2021-03-19 | Traditional | PDF ↗ |
| K202475 | PALACOS R, PALACOS R pro, PALACOS R+G, PALACOS R+G pro, PALACOS MV+G | Heraeus Medical GmbH | 2020-11-23 | Traditional | PDF ↗ |
| K193059 | G1 40 Radiopaque Bone Cement | G21, S.R.L. | 2020-03-19 | Traditional | PDF ↗ |
| K193061 | G3 40 Radiopaque Bone Cement | G21, S.R.L. | 2020-03-19 | Traditional | PDF ↗ |
| K192394 | Hi-Fatigue Bone Cement | Osartis GmbH | 2019-12-02 | Traditional | PDF ↗ |
| K192379 | Hi-Fatigue G Bone Cement | Osartis GmbH | 2019-11-27 | Traditional | PDF ↗ |
| K190766 | PALACOS fast R+G | Heraeus Medical GmbH | 2019-05-31 | Traditional | PDF ↗ |
| K181282 | G3A 40 Bone Cement | G21, S.R.L. | 2019-01-09 | Traditional | PDF ↗ |
| K182260 | PALACOS MV | Heraeus Medical GmbH | 2018-09-17 | Special | PDF ↗ |
| K173494 | OrthoSteady G Bone Cement | G21, S.R.L. | 2018-03-06 | Traditional | PDF ↗ |
| K172408 | Biomet Bone Cement R | Biomet, Inc. | 2017-10-05 | Traditional | PDF ↗ |
| K170802 | TRAUMACEM V+ Injectable Bone Cement | Synthes (USA) Products, LLC | 2017-09-28 | Traditional | PDF ↗ |
| K171540 | Refobacin Bone Cement R | Biomet, Inc. | 2017-08-30 | Traditional | PDF ↗ |
| K153737 | OSTEOPAL plus | Heraeus Medical GmbH | 2016-04-22 | Special | PDF ↗ |
| K150408 | V-STEADY, V-FAST | G21, S.R.L. | 2015-12-14 | Traditional | PDF ↗ |
| K150119 | PALACOS R pro | Heraeus Medical GmbH | 2015-06-17 | Special | PDF ↗ |
| K143134 | NP Cement HV;NP Cement LV; NP Cement HV System; NP Cement LV System | Cossington, Ltd. | 2015-03-05 | Traditional | PDF ↗ |
| K143100 | NP Cement HV Genta;NP Cement LV Genta;NP Cement HV System Genta;NP Cement LV System Genta | Cossington, Ltd. | 2015-03-05 | Traditional | PDF ↗ |
| K142157 | PALACOS R+G PRO | Heraeus Medical GmbH | 2014-09-05 | Special | PDF ↗ |
| K123225 | BONOS R 1X20, BONOS R 2X20, BONOS R 1X40, BONOS R 2X40, BONOS R 1X60 | Aap Biomaterials GmbH & Co. KG | 2013-03-15 | Abbreviated | PDF ↗ |
| K123081 | 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 | Aap Biomaterials GmbH & Co. KG | 2013-03-07 | Abbreviated | PDF ↗ |
| K092773 | CEMEX GENTA, GENTA SYSTEM AND GENTA SYSTEM FAST | Tecres S.P.A. | 2009-11-24 | Special | PDF ↗ |
| K092150 | COBALT MV WITH GENTAMICIN (AKA COBALT G-MV) BONE CEMENT | Biomet, Inc. | 2009-10-27 | Traditional | PDF ↗ |
| K091608 | COBALT MV BONE CEMENT | Biomet Manufacturing Corp | 2009-09-17 | Traditional | PDF ↗ |
| K081155 | SMARTSET MV BONE CEMENT | DePuy Orthopaedics, Inc. | 2008-05-14 | Special | PDF ↗ |
| K070015 | COBALT V RADIOPAQUE VERTEBROPLASTY BONE CEMENT | Biomet Manufacturing Corp | 2007-11-30 | Abbreviated | PDF ↗ |
| K062553 | SIMPLEX P BONE CEMENT | Stryker Orthopaedics | 2007-01-08 | Traditional | PDF ↗ |
| K053198 | SIMPLEX P SPEEDSET BONE CEMENT | Howmedica Osteonics Corp. | 2006-01-26 | Traditional | PDF ↗ |
| K053445 | SMARTMIX CEMVAC PRE-FILLED WITH SMARTSET HV BONE CEMENT | DePuy Orthopaedics, Inc. | 2006-01-06 | Traditional | PDF ↗ |
| K053003 | DEPUY CMW 1, 2 AND 3 BONE CEMENTS | DePuy Orthopaedics, Inc. | 2005-11-22 | Special | PDF ↗ |
| K050085 | OSTEOPAL V | Heraeus Kulzer,GmbH | 2005-09-14 | Abbreviated | PDF ↗ |
| K051496 | COBALT BONE CEMENT | Biomet, Inc. | 2005-08-04 | Traditional | PDF ↗ |
| K051532 | COBALT G HV BONE CEMENT | Biomet, Inc. | 2005-08-03 | Traditional | PDF ↗ |
| K050854 | PALACOS LV+G | Heraeus Kulzer,GmbH | 2005-07-07 | Traditional | PDF ↗ |
| K050855 | PALAMED G | Heraeus Kulzer,GmbH | 2005-07-07 | Traditional | PDF ↗ |
| K043403 | CEMEX SYSTEM GENTA FAST BONE CEMENT | Exactech, Inc. | 2004-12-28 | Special | PDF ↗ |
| K041656 | MODIFICATION TO DEPUY 1 GENTAMICIN BONE CEMENT AND SMARTSET GMV ENDURANCE GENTAMICIN BONE CEMENT | DePuy Orthopaedics, Inc. | 2004-07-01 | Special | PDF ↗ |
| K032945 | SIMPLEX X | Stryker Corp. | 2004-05-25 | Traditional | PDF ↗ |
| K031673 | REFOBACIN -PALACOS G | Heraeus Kulzer GmbH & Co. KG | 2004-05-25 | Traditional | PDF ↗ |
| K033596 | CEMEX GENTA BONE CEMENT; CEMEX GENTA SYSTEM BONE CEMENT | Exactech, Inc. | 2004-05-10 | Traditional | PDF ↗ |
| K022688 | VERSABOND AB BONE CEMENT | Smith & Nephew, Inc. | 2004-04-29 | Abbreviated | PDF ↗ |
| K033382 | SMARTSET GMV ENDURANCE GENTAMICIN BONE CEMENT | DePuy Orthopaedics, Inc. | 2004-02-05 | Traditional | PDF ↗ |
| K033563 | SMARTSET GHV GENTAMICIN BONE CEMENT | DePuy Orthopaedics, Inc. | 2004-02-05 | Traditional | PDF ↗ |
| K030086 | PALACOS R BONE CEMENT WITH GENTAMICIN | Biomet, Inc. | 2003-12-17 | Traditional | PDF ↗ |
| K033509 | MODIFICATION TO VERSABOND BONE CEMENT | Smith & Nephew, Inc. | 2003-11-28 | Special | PDF ↗ |
| K023103 | DEPUY 1 GENTAMICIN BONE CEMENT | DePuy Orthopaedics, Inc. | 2003-09-29 | Traditional | PDF ↗ |
| K030902 | PALACOS R | Heraeus Kulzer GmbH & Co. KG | 2003-09-23 | Abbreviated | PDF ↗ |
| K030903 | OSTEOPAL | Heraeus Kulzer GmbH & Co. KG | 2003-09-23 | Abbreviated | PDF ↗ |
| K030904 | PALAMED | Heraeus Medical GmbH Technology | 2003-09-23 | Abbreviated | PDF ↗ |
| K031430 | CEMEX SYSTEM FAST | Exactech, Inc. | 2003-05-22 | Special | PDF ↗ |
| K014199 | SURGICAL SIMPLEX P WITH TOBRAMYCIN | Howmedica Osteonics Corp. | 2003-05-06 | Traditional | PDF ↗ |
| K022251 | PALABOND | Heraeus Kulzer GmbH & Co. KG | 2003-02-26 | Abbreviated | PDF ↗ |
| K023012 | SMARTSET HV BONE CEMENT | DePuy Orthopaedics, Inc. | 2003-02-13 | Traditional | PDF ↗ |
| K021499 | CEMVAC ULTRA PRE-PACKED WITH DEPUY 1 BONE CEMENT | DePuy Orthopaedics, Inc. | 2002-07-24 | Traditional | PDF ↗ |
| K021715 | CEMEX RX, CEMEX ISOPLASTIC & CEMEX XL | Exactech, Inc. | 2002-06-12 | Special | PDF ↗ |
| K013755 | CONCERT RADIOPAQUE BONE CEMENT | Immedica, Inc. | 2002-02-08 | Traditional | PDF ↗ |
| K993836 | GENERATION 4 BONE CEMENT | Biomet, Inc. | 2001-12-19 | Traditional | PDF ↗ |
| K010586 | PALAMED BONE CEMENT | Merck Biomaterial GmbH | 2001-10-30 | Traditional | PDF ↗ |
| K000943 | CEMEX SYSTEM GUN APPLICATION VERSION | Exactech, Inc. | 2001-02-08 | Traditional | PDF ↗ |
| K002652 | SURGICAL SIMPLEX P RADIOPAQUE BONE CEMENT AND ACM AND MIXEVACII | Stryker Corp. | 2001-01-26 | Traditional | PDF ↗ |
| K001160 | VERSABOND BONE CEMENT | Smith & Nephew, Inc. | 2000-12-11 | Abbreviated | PDF ↗ |
Product code LOD · Class II · Orthopedic. Data: openFDA.