FDA.reportPublic FDA data

Orthopaedic cement, non-medicated

Definition
A substance designed to be used in arthroplastic and/or osteosynthetic procedures for the fixation of polymer or metallic implants to the living bone. It may also be intended for use as a filler in the case of bone pathologies (e.g., to stabilize and reinforce vertebral body structures in vertebroplasty and kyphoplasty). It is typically made from methylmethacrylate, polymethylmethacrylate (PMMA), esters of methacrylic acid or copolymers containing polymethylmethacrylate and polystyrene. This device does not contain an antimicrobial agent. After application, this device cannot be reused.
GUDID devices
132
Last updated
2020-04-29 00:28:35

Representative GUDID Devices#

Primary DI, Brand, Company table
Primary DIBrandCompanyModelPublished
00887868214578BIOMET® BONE CEMENT RBIOMET1100353682018-04-04
00887868214608BIOMET® BONE CEMENT RBIOMET1100353712018-04-04
00841036020811Mimix QSBIOMET MICROFIXATION, INC02-11052015-09-11
00841036020828Mimix QSBIOMET MICROFIXATION, INC02-11102015-09-11
00841036020965MIMIXBIOMET MICROFIXATION, INC02-20052015-09-11
00841036020996MIMIXBIOMET MICROFIXATION, INC02-20102015-09-11
00841036021009MIMIXBIOMET MICROFIXATION, INC02-20252015-09-11
00841036141943OTOMIMIXBIOMET MICROFIXATION, INC7014-32662015-09-11
00827002313941VertefixCOOK INCORPORATEDG313942016-04-28
00190446258957DJO SURGICALEncore Medical, L.P.60060005-022019-07-18
00190446258964DJO SURGICALEncore Medical, L.P.60060005-012019-07-18
00190446262121DJO SURGICALEncore Medical, L.P.600-60-0042019-08-19
00190446262626DJO SURGICALEncore Medical, L.P.600600042019-08-19
00190446262633DJO SURGICALEncore Medical, L.P.60060004-012019-08-19
00190446262640DJO SURGICALEncore Medical, L.P.60060004-022019-08-19
00190446262657DJO SURGICALEncore Medical, L.P.60060004-032019-08-19
00190446262664DJO SURGICALEncore Medical, L.P.60060004-042019-08-19
00190446283676DJO SURGICALEncore Medical, L.P.600-60-0032019-08-19
00190446285557DJO SURGICALEncore Medical, L.P.600-60-0052019-07-18
08058964720047G3 40 Radiopaque Bone CementG21 SRL8000042020-04-01
08058964723970G1 40 Radiopaque Bone CementG21 SRL8000022020-04-01
23596010411024VERSABONDSmith & Nephew, Inc.712711402015-08-29
23596010494720VERSABONDSmith & Nephew, Inc.712713402015-08-29
23596010507376VERSABONDSmith & Nephew, Inc.712714402015-09-28
00884450314081StabiliT®Merit Medical Systems, Inc.008844503140812019-10-31
00884450314074StabiliT®Merit Medical Systems, Inc.008844503140742019-09-13
20603295168338SMARTSETDEPUY (IRELAND)3092-0402015-09-24
20603295168352SMARTSETDEPUY (IRELAND)3102-0802015-09-24
20603295168369SMARTSETDEPUY (IRELAND)3122-0202015-09-24
30603295168328SMARTSETDEPUY (IRELAND)3092-0202015-09-24
30603295168373SMARTSETDEPUY (IRELAND)3122-0402015-09-24
30603295168618NADEPUY (IRELAND)3312-0402015-09-24
30603295168625NADEPUY (IRELAND)3322-0202015-09-24
30603295168632NADEPUY (IRELAND)3332-0402015-09-24
15056033810538OsteoflexPAN MEDICAL US CORPORATIONINTV-CEM2016-11-04
28031497000019Cemex RXTECRES SPA1200/A2015-10-08
28031497000033CEMEX ISOPLASTICTECRES SPA1200/I2015-10-08
28031497000057CEMEX XLTECRES SPA1200/S2015-10-08
28031497000071CEMEX ISOPLASTIC 1/2 PACKTECRES SPA1220/I2015-10-08
B578001112140011PALACOSHeraeus Medical GmbHR2017-09-01
B578001113140011PALACOSHeraeus Medical GmbHR+G2017-09-01
B5780011181400114PALACOS Heraeus Medical GmbHLV2017-09-01
B5780011191400115PALACOSHeraeus Medical GmbHLV+G2017-09-01
04250337103332Kyverment®Joimax GmbHJMSPACE1002016-09-24
14260056885621BonOs R 1x40OSARTIS GmbH01-01172015-09-25
24260056885741Simplex HVOSARTIS GmbH6194-1-0012015-09-24
04260102135505PALACOS®Heraeus Medical GmbHR2018-01-01
04260102135536PALACOS®Heraeus Medical GmbHR+G2018-01-01
04260102135567PALACOS®Heraeus Medical GmbHLV2018-01-01
04260102135598PALACOS®Heraeus Medical GmbHLV+G2018-01-01
04260102135826PALACOS®Heraeus Medical GmbHMV+G2018-03-16
04260102135857PALACOS®Heraeus Medical GmbHMV2018-03-16
04260102135970PALACOS® Heraeus Medical GmbHR pro2018-06-01
04260102136007PALACOS® Heraeus Medical GmbHR+G pro2018-06-01
04260102136601PALACOS®Heraeus Medical GmbHMV2018-11-16
34546540039638BioPrepSTRYKER CORPORATION02067100002015-09-23
34546540434365SpinePlexSTRYKER CORPORATION04062020002016-06-30
05019279925377Cobalt MV Bone CementBiomet Orthopedics, LLC4024382015-11-28
37613154757092VertaPlexSTRYKER CORPORATION04064020002016-06-30
37613327128445SimplexHowmedica Osteonics Corp.6191-1-0012015-09-24
57613327128432SimplexHowmedica Osteonics Corp.6188-1-0012015-09-24
37613327141765VertaPlexSTRYKER CORPORATION04064020022016-09-23
37613327141789SpinePlexSTRYKER CORPORATION04062020102016-09-23
57613327141776SpinePlexSTRYKER CORPORATION04062220002016-09-23
57613327170561VertaPlexSTRYKER CORPORATION04064020152016-09-23
00850696006028StabiliT Bone Cement and Saturate Mixing SystemDfine, Inc.44572015-12-17
00850696006073StabiliT VP Fracture KitDfine, Inc.VP-0010A2015-12-11
00850696006226StabiliT First Fracture Kit Dfine, Inc.2003-12015-11-02
00850696006233StabiliT First Fracture Kit Dfine, Inc.3353-012016-01-27
00850696006288StabiliT MX Fracture Kit Dfine, Inc.MX-2100L-012015-11-30
00850696006295StabiliT MX Fracture Kit Dfine, Inc.MX-2100S-012015-11-30
00850696006301StabiliT MX Fracture Kit Dfine, Inc.MX-1100L-012015-11-30
00850696006318StabiliT MX Fracture Kit Dfine, Inc.MX-1100S-012015-11-30
00850696006370StabiliT Complete Fracture Kit Dfine, Inc.3506-012016-03-23
00850696006387StabiliT Complete Fracture Kit Dfine, Inc.3512-012016-03-23
00850696006394StabiliT Second Fracture Kit Dfine, Inc.1666-012016-03-23
00850696006400StabiliT Second Fracture KitDfine, Inc.1436-012016-03-23
00850696006417StabiliT ER2 Bone CementDfine, Inc.11352015-12-17
00850696006424StabiliT ER2 Bone Cement and Saturate Mixing SystemDfine, Inc.16882015-12-17
00850696006431StabiliT ER2 Bone Cement, Single - LevelDfine, Inc.33662015-12-17