Product code LOD
- Product
- Radiation Emitting Electronic Codes // Quick Links: Skip To Main Page Content Skip To Search Skip To Topics Menu Skip To Common Links U.S. Food & Drug Administration Follow FDA En Español Search FDA Home Food Drugs Medical De
- Definition
- Radiation Emitting Electronic Product Codes // Quick Links: Skip To Main Page Content Skip To Search Skip To Topics Menu Skip To Common Links U.S. Food & Drug Administration Follow FDA En Español Search FDA Home Food Drugs Medical Devices Radiation-Emitting Products Vaccines, Blood & Biologics Animal & Veterinary Co
- Description
- Radiation Emitting Electronic Product Codes // Quick Links: Skip To Main Page Content Skip To Search Skip To Topics Menu Skip To Common Links U.S. Food & Drug Administration Follow FDA En Español Search FDA Home Food Drugs Medical Devices Radiation-Emitting Products Vaccines, Blood & Biologics Animal & Veterinary Cosmetics Tobacco Products Radiation Emitting Electronic Product Codes Var MP = { Version: '1.0.22', Domains: {'es':'esp.fda.gov'}, SrcLang: 'en', UrlLang: 'mp_js_current_lang', SrcUrl: Unescape('mp_js_orgin_url'), Init: Function(){ If (MP.UrlLang.indexOf('p_js_')==1) { MP.SrcUrl=window.top.document.location.href; MP.UrlLang=MP.SrcLang; } }, GetCookie: Function(name){ Var Start=document.cookie.indexOf(name+'='); If(start < 0) Return Null; Start=start+name.length+1; Var End=document.cookie.indexOf(';', Start); If(end < 0) End=document.cookie.length; While (document.cookie.charAt(start)==' '){ Start++; } Return Unescape(document.cookie.substring(start,end)); }, SetCookie: Function(name,value,path,domain){ Var Cookie=name+'='+escape(value); If(path)cookie+='; Path='+path; If(domain)cookie+='; Domain='+domain; Var Now=new Date(); Now.setTime(now.getTime()+1000*60*60*24*365); Cookie+='; Expires='+now.toUTCString(); Document.cookie=cookie; }, SwitchLanguage: Function(lang){ If(lang!=MP.SrcLang){ Var Script=document.createElement('SCRIPT'); Script.src=location.protocol+'//'+MP.Domains[lang]+'/'+MP.SrcLang+lang+'/?1023749632;'+encodeURIComponent(MP.SrcUrl); Document.body.appendChild(script); } Else If(lang==MP.SrcLang && MP.UrlLang!=MP.SrcLang){ Var Script=document.createElement('SCRIPT'); Script.src=location.protocol+'//'+MP.Domains[MP.UrlLang]+'/'+MP.SrcLang+MP.UrlLang+'/?1023749634;'+encodeURIComponent(location.href); Document.body.appendChild(script); } Return False; }, SwitchToLang: Function(url) { Window.top.location.href=url; } }; Var Addthis_config = {data_track_clickback: True, Ui_508_compliant: True, Services_compact: 'facebook, Twitter, Linkedin, Pinterest_share, Email', Services_exclude: 'print', Image_container: "#user_provided" } ; FDA Home Medical Devices Databases -
- Regulation number
- Radiation type
- Radiation Emitting Electronic Product Codes // Qui
- Applicable standards
- Radiation Emitting Electronic Product Codes // Quick Links: Skip To Main Page Content Skip To Search Skip To Topics Menu Skip To Common Links U.S. Food & Drug Administration Follow FDA En Español Search FDA Home Food Drugs Medical Devices Radiation-Emitting Products Vaccines, Blood & Biologics Animal & Veterinary Cosmetics Tobacco Products Radiation Emitting Electronic Product Codes Var MP = { Version: '1.0.22', Domains: {'es':'esp.fda.gov'}, SrcLang: 'en', UrlLang: 'mp_js_current_lang', SrcUrl: Unescape('mp_js_orgin_url'), Init: Function(){ If (MP.UrlLang.indexOf('p_js_')==1) { MP.SrcUrl=window.top.document.location.href; MP.UrlLang=MP.SrcLang; } }, GetCookie: Function(name){ Var Start=document.cookie.indexOf(name+'='); If(start < 0) Return Null; Start=start+name.length+1; Var End=document.cookie.indexOf(';', Start); If(end < 0) End=document.cookie.length; While (document.cookie.charAt(start)==' '){ Start++; } Return Unescape(document.cookie.substring(start,end)); }, SetCookie: Function(name,value,path,domain){ Var Cookie=name+'='+escape(value); If(path)cookie+='; Path='+path; If(domain)cookie+='; Domain='+domain; Var Now=new Date(); Now.setTime(now.getTime()+1000*60*60*24*365); Cookie+='; Expires='+now.toUTCString(); Document.cookie=cookie; }, SwitchLanguage: Function(lang){ If(lang!=MP.SrcLang){ Var Script=document.createElement('SCRIPT'); Script.src=location.protocol+'//'+MP.Domains[lang]+'/'+MP.SrcLang+lang+'/?1023749632;'+encodeURIComponent(MP.SrcUrl); Document.body.appendChild(script); } Else If(lang==MP.SrcLang && MP.UrlLang!=MP.SrcLang){ Var Script=document.createElement('SCRIPT'); Script.src=location.protocol+'//'+MP.Domains[MP.UrlLang]+'/'+MP.SrcLang+MP.UrlLang+'/?1023749634;'+encodeURIComponent(location.href); Document.body.appendChild(script); } Return False; }, SwitchToLang: Function(url) { Window.top.location.href=url; } }; var Addthis_config = {data_track_clickback: True, Ui_508_compliant: True, Services_compact: 'facebook, Twitter, Linkedin, Pinterest_share, Email', Services_exclude: 'print', Image_container: "#user_provided" } ; FDA Home Medical Devices Databases -
Current FDA Classification
- Device name
- Bone Cement
- Medical specialty
- Orthopedic
- Device class
- 2
- Regulation number
- 888.3027
- Review panel
- OR
- Implant
- Y
- Life sustaining/supporting
- N
- GMP exempt
- N
- Third party review
- N
- Summary malfunction reporting
- Eligible
Related Records
Related PMA Records
| PMA | Device | Applicant | Decision date |
|---|---|---|---|
| N17004S013 | SURGICAL SIMPLEX P BONE CEMENT | HOWMEDICA CORP. | 2000-12-15 |
| P970010S004 | NORIAN SRS BONE CEMENT | SYNTHES (USA) | 2000-08-31 |
| N17004S012 | SURGICAL SIMPLEX P RADIOPAQUE BONE CEMENT | HOWMEDICA CORP. | 2000-06-20 |
| P970010S002 | NORIAN SRS CEMENT | SYNTHES (USA) | 2000-04-28 |
| N17004S011 | SURGICAL SIMPLEX(R) P RADIOPAQUE BONE CEMENT | HOWMEDICA CORP. | 1998-03-18 |
| N17004S010 | SURGICAL SIMPLEX(R) P RADIOPAQUE BONE CEMENT | HOWMEDICA CORP. | 1997-11-13 |
| N17004S009 | SURGICAL SIMPLEX(R) P RADIOPAQUE BONE CEMENT | HOWMEDICA CORP. | 1997-08-08 |
| N17004S008 | SURGICAL SIMPLEX(R) P RADIOPAQUE BONE CEMENT | HOWMEDICA CORP. | 1996-12-18 |
| N17004S006 | SURGICAL SIMPLEX(R) P RADIOPAQUE BONE CEMENT | HOWMEDICA CORP. | 1995-02-24 |
| N17004S004 | SURGICAL SIMPLEX(R) P RADIOPAQUE BONE CEMENT | HOWMEDICA CORP. | 1994-12-30 |
| N17004S003 | SURGICAL SIMPLEX(R) P RADIOPAQUE BONE CEMENT | HOWMEDICA CORP. | 1992-10-01 |
| N17004S002 | SURGICAL SIMPLEX(R) P RADIOPAQUE BONE CEMENT | HOWMEDICA CORP. | 1991-03-07 |
| N17004S001 | SURGICAL SIMPLEX RADIOPAQUE BONE CEMENT | HOWMEDICA CORP. | 1981-11-13 |
| N17004 | SURGICAL SIMPLEX P RADEOPAQUE BONE CEMENT | HOWMEDICA CORP. | 1971-10-07 |
Related 510(k) Records
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K254107 | Refobacin Bone Cement R (110034355) | Biomet France | 2026-04-15 |
| K250760 | SPECTRUM GV Bone Cement | Osteoremedies, LLC | 2025-04-02 |
| K241674 | OSTEOPAL® V | Heraeus Medical GmbH | 2024-12-05 |
| K231556 | SPECTRUM® GV Bone Cement | Osteoremedies, LLC | 2023-12-20 |
| K211163 | Bone Cement Genta, Bone Cement HV, Bone Cement LV | Tecres S.P.A. | 2023-01-09 |
| K212729 | Bone Cement-Normal Viscosity | Biomecanica Industria E Comerciode Produtos Ortopedicos Ltda | 2022-05-31 |
| K211869 | OGM 1 Polymethylmethacrylate (PMMA) bone cement, OGM 1A Polymethylmethacrylate (PMMA) bone cement | Ormed Grup Medikal Turizm Saglik Hizmetleri Sanayi VE | 2022-05-19 |
| K213812 | PALACOS MV pro | Heraeus Medical GmbH | 2022-02-02 |
| K210607 | PALACOS R pro, PALACOS R+G pro, PALACOS MV+G pro | Heraeus Medical GmbH | 2021-07-09 |
| K202458 | BonOs Inject, Pedicle screw kits, Cement pusher | Osartis GmbH | 2021-05-18 |
| K210125 | BonOs HV Genta, BonOs MV Genta, BonOs LV Genta | Osartis GmbH | 2021-03-19 |
| K210120 | BonOs HV, BonOs MV, BonOs LV | Osartis GmbH | 2021-03-19 |
| K202475 | PALACOS R, PALACOS R pro, PALACOS R+G, PALACOS R+G pro, PALACOS MV+G | Heraeus Medical GmbH | 2020-11-23 |
| K193059 | G1 40 Radiopaque Bone Cement | G21, S.R.L. | 2020-03-19 |
| K193061 | G3 40 Radiopaque Bone Cement | G21, S.R.L. | 2020-03-19 |
| K192394 | Hi-Fatigue Bone Cement | Osartis GmbH | 2019-12-02 |
| K192379 | Hi-Fatigue G Bone Cement | Osartis GmbH | 2019-11-27 |
| K190766 | PALACOS fast R+G | Heraeus Medical GmbH | 2019-05-31 |
| K181282 | G3A 40 Bone Cement | G21, S.R.L. | 2019-01-09 |
| K182260 | PALACOS MV | Heraeus Medical GmbH | 2018-09-17 |
| K173494 | OrthoSteady G Bone Cement | G21, S.R.L. | 2018-03-06 |
| K172408 | Biomet Bone Cement R | Biomet, Inc. | 2017-10-05 |
| K170802 | TRAUMACEM V+ Injectable Bone Cement | Synthes (USA) Products, LLC | 2017-09-28 |
| K171540 | Refobacin Bone Cement R | Biomet, Inc. | 2017-08-30 |
| K153737 | OSTEOPAL plus | Heraeus Medical GmbH | 2016-04-22 |
| K150408 | V-STEADY, V-FAST | G21, S.R.L. | 2015-12-14 |
| K150119 | PALACOS R pro | Heraeus Medical GmbH | 2015-06-17 |
| K143100 | NP Cement HV Genta;NP Cement LV Genta;NP Cement HV System Genta;NP Cement LV System Genta | Cossington, Ltd. | 2015-03-05 |
| K143134 | NP Cement HV;NP Cement LV; NP Cement HV System; NP Cement LV System | Cossington, Ltd. | 2015-03-05 |
| K142157 | PALACOS R+G PRO | Heraeus Medical GmbH | 2014-09-05 |
Related GUDID Devices
| Primary DI | Brand | Company | Published |
|---|---|---|---|
| 03760177044333 | Signature -x Cement | TEKNIMED | 2026-01-23 |
| 03760177044340 | Signature -x Cement | TEKNIMED | 2026-01-23 |
| 03760177044326 | Signature -x Cement | TEKNIMED | 2026-01-23 |
| 04260102139428 | OSTEOPAL® | Heraeus Medical GmbH | 2025-09-26 |
| 03760177040090 | GENTAFIX | TEKNIMED | 2025-09-02 |
| 03760177040137 | GENTAFIX | TEKNIMED | 2025-09-02 |
| 03760177043176 | GENTAFIX | TEKNIMED | 2025-09-02 |
| 07898315500901 | Bone Cement - Normal Viscosity | Biomecânica Indústria e Comércio de Produtos Ortopédicos Ltda. | 2025-04-23 |
| 08058964729033 | Arthrex Bone Cement HV | G21 SRL | 2024-10-04 |
| 08058964729040 | Arthrex Bone Cement MV | G21 SRL | 2024-10-04 |
| 08058964729002 | BRAVO MV | G21 SRL | 2024-09-16 |
| 08058964729026 | BRAVO HV+G | G21 SRL | 2024-09-16 |
| 08058964729019 | BRAVO MV+G | G21 SRL | 2024-09-16 |
| 08058964728746 | Arthrex Bone Cement MV w/G | G21 SRL | 2024-09-16 |
| 08058964728739 | Arthrex Bone Cement MV | G21 SRL | 2024-09-16 |
| 08058964728722 | Arthrex Bone Cement HV w/G | G21 SRL | 2024-09-16 |
| 08058964728678 | BRAVO HV | G21 SRL | 2024-09-16 |
| 08058964728647 | Arthrex Bone Cement HV | G21 SRL | 2024-09-16 |
| 04260056882579 | BonOs HV | OSARTIS GmbH | 2024-05-17 |
| 04260102135338 | PALACOS® | Heraeus Medical GmbH | 2022-02-13 |
| 04260102135376 | PALACOS® | Heraeus Medical GmbH | 2022-02-13 |
| 00815212023484 | KIT:VCF TREATMENT,RIGHT,FRACTURE | Izi Medical Products, LLC | 2021-10-15 |
| 00815212023491 | KIT:VCF TREATMENT,LEFT,FRACTURE | Izi Medical Products, LLC | 2021-10-15 |
| 00815212023507 | PILOT:GEN A,RIGHT | Izi Medical Products, LLC | 2021-10-15 |
| 00815212023514 | PILOT:GEN A,LEFT | Izi Medical Products, LLC | 2021-10-15 |
| 00815212023590 | KIVA ULTRAFLEX CEMENT NEEDLE KIT | Izi Medical Products, LLC | 2021-10-15 |
| 00815212023606 | KIVA INTRODUCER SET | Izi Medical Products, LLC | 2021-10-15 |
| 04260102136120 | PALACOS® | Heraeus Medical GmbH | 2021-07-15 |
| 10886982262257 | TRAUMACEM | Synthes GmbH | 2017-10-06 |
| 50885380066519 | CARDINAL HEALTH | Cardinal Health 200, LLC | 2015-07-06 |