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

PMADeviceApplicantDecision date
N17004S013SURGICAL SIMPLEX P BONE CEMENTHOWMEDICA CORP.2000-12-15
P970010S004NORIAN SRS BONE CEMENTSYNTHES (USA)2000-08-31
N17004S012SURGICAL SIMPLEX P RADIOPAQUE BONE CEMENTHOWMEDICA CORP.2000-06-20
P970010S002NORIAN SRS CEMENTSYNTHES (USA)2000-04-28
N17004S011SURGICAL SIMPLEX(R) P RADIOPAQUE BONE CEMENTHOWMEDICA CORP.1998-03-18
N17004S010SURGICAL SIMPLEX(R) P RADIOPAQUE BONE CEMENTHOWMEDICA CORP.1997-11-13
N17004S009SURGICAL SIMPLEX(R) P RADIOPAQUE BONE CEMENTHOWMEDICA CORP.1997-08-08
N17004S008SURGICAL SIMPLEX(R) P RADIOPAQUE BONE CEMENTHOWMEDICA CORP.1996-12-18
N17004S006SURGICAL SIMPLEX(R) P RADIOPAQUE BONE CEMENTHOWMEDICA CORP.1995-02-24
N17004S004SURGICAL SIMPLEX(R) P RADIOPAQUE BONE CEMENTHOWMEDICA CORP.1994-12-30
N17004S003SURGICAL SIMPLEX(R) P RADIOPAQUE BONE CEMENTHOWMEDICA CORP.1992-10-01
N17004S002SURGICAL SIMPLEX(R) P RADIOPAQUE BONE CEMENTHOWMEDICA CORP.1991-03-07
N17004S001SURGICAL SIMPLEX RADIOPAQUE BONE CEMENTHOWMEDICA CORP.1981-11-13
N17004SURGICAL SIMPLEX P RADEOPAQUE BONE CEMENTHOWMEDICA CORP.1971-10-07

Related 510(k) Records

510(k)DeviceApplicantDecision date
K254107Refobacin Bone Cement R (110034355)Biomet France2026-04-15
K250760SPECTRUM GV Bone CementOsteoremedies, LLC2025-04-02
K241674OSTEOPAL® VHeraeus Medical GmbH2024-12-05
K231556SPECTRUM® GV Bone CementOsteoremedies, LLC2023-12-20
K211163Bone Cement Genta, Bone Cement HV, Bone Cement LVTecres S.P.A.2023-01-09
K212729Bone Cement-Normal ViscosityBiomecanica Industria E Comerciode Produtos Ortopedicos Ltda2022-05-31
K211869OGM 1 Polymethylmethacrylate (PMMA) bone cement, OGM 1A Polymethylmethacrylate (PMMA) bone cementOrmed Grup Medikal Turizm Saglik Hizmetleri Sanayi VE2022-05-19
K213812PALACOS MV proHeraeus Medical GmbH2022-02-02
K210607PALACOS R pro, PALACOS R+G pro, PALACOS MV+G proHeraeus Medical GmbH2021-07-09
K202458BonOs Inject, Pedicle screw kits, Cement pusherOsartis GmbH2021-05-18
K210125BonOs HV Genta, BonOs MV Genta, BonOs LV GentaOsartis GmbH2021-03-19
K210120BonOs HV, BonOs MV, BonOs LVOsartis GmbH2021-03-19
K202475PALACOS R, PALACOS R pro, PALACOS R+G, PALACOS R+G pro, PALACOS MV+GHeraeus Medical GmbH2020-11-23
K193059G1 40 Radiopaque Bone CementG21, S.R.L.2020-03-19
K193061G3 40 Radiopaque Bone CementG21, S.R.L.2020-03-19
K192394Hi-Fatigue Bone CementOsartis GmbH2019-12-02
K192379Hi-Fatigue G Bone CementOsartis GmbH2019-11-27
K190766PALACOS fast R+GHeraeus Medical GmbH2019-05-31
K181282G3A 40 Bone CementG21, S.R.L.2019-01-09
K182260PALACOS MVHeraeus Medical GmbH2018-09-17
K173494OrthoSteady G Bone CementG21, S.R.L.2018-03-06
K172408Biomet Bone Cement RBiomet, Inc.2017-10-05
K170802TRAUMACEM™ V+ Injectable Bone CementSynthes (USA) Products, LLC2017-09-28
K171540Refobacin Bone Cement RBiomet, Inc.2017-08-30
K153737OSTEOPAL plusHeraeus Medical GmbH2016-04-22
K150408V-STEADY, V-FASTG21, S.R.L.2015-12-14
K150119PALACOS R proHeraeus Medical GmbH2015-06-17
K143100NP Cement HV Genta;NP Cement LV Genta;NP Cement HV System Genta;NP Cement LV System GentaCossington, Ltd.2015-03-05
K143134NP Cement HV;NP Cement LV; NP Cement HV System; NP Cement LV SystemCossington, Ltd.2015-03-05
K142157PALACOS R+G PROHeraeus Medical GmbH2014-09-05

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Primary DIBrandCompanyPublished
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08058964729033Arthrex Bone Cement HVG21 SRL2024-10-04
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08058964729026BRAVO HV+GG21 SRL2024-09-16
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08058964728746Arthrex Bone Cement MV w/GG21 SRL2024-09-16
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08058964728722Arthrex Bone Cement HV w/GG21 SRL2024-09-16
08058964728678BRAVO HVG21 SRL2024-09-16
08058964728647Arthrex Bone Cement HVG21 SRL2024-09-16
04260056882579BonOs HVOSARTIS GmbH2024-05-17
04260102135338PALACOS®Heraeus Medical GmbH2022-02-13
04260102135376PALACOS®Heraeus Medical GmbH2022-02-13
00815212023484KIT:VCF TREATMENT,RIGHT,FRACTUREIzi Medical Products, LLC2021-10-15
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00815212023590KIVA ULTRAFLEX CEMENT NEEDLE KIT Izi Medical Products, LLC2021-10-15
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10886982262257TRAUMACEMSynthes GmbH2017-10-06
50885380066519CARDINAL HEALTHCardinal Health 200, LLC2015-07-06