LOD

Product Code: LOD


Products Classified as LOD

4596Bone CementPolymethylmethacrylate (PMMA) Bone Cement.

Total Product Life Cycle (TPLC) Devices

4596Bone CementPolymethylmethacrylate (PMMA) Bone Cement.

FDA Consensus Standards

Bone Cement [37410]21 CFR §888.3027 🔎
Bone Cement [37411]21 CFR §888.3027 🔎
Bone Cement [35609]21 CFR §888.3027 🔎

Pre-market Approvals for LOD

P970010NORIAN SRS BONE CEMENTSYNTHES (USA)
N17004SURGICAL SIMPLEX P BONE CEMENTHOWMEDICA CORP.

Pre-market Notifications for LOD

K213812PALACOS MV ProHeraeus Medical GmbH
K211869OGM 1 Polymethylmethacrylate (PMMA) Bone Cement, OGM 1A Polymethylmethacrylate (PMMA) Bone CementOrmed Grup Medikal Turizm Saglik Hizmetleri Sanayi Ve
K210607PALACOS R Pro, PALACOS R+G Pro, PALACOS MV+G ProHeraeus Medical GmbH
K210125BonOs HV Genta, BonOs MV Genta, BonOs LV GentaOSARTIS GmbH
K210120BonOs HV, BonOs MV, BonOs LVOsartis GmbH
K193059G1 40 Radiopaque Bone CementG21 S.r.l.
K193061G3 40 Radiopaque Bone CementG21 S.r.l
K192394Hi-Fatigue Bone CementOSARTIS GmbH
K192379Hi-Fatigue G Bone CementOSARTIS GmbH
K190766PALACOS Fast R+GHeraeus Medical GmbH
K182260PALACOS MVHeraeus Medical GmbH
K181282G3A 40 Bone CementG21 S.r.l
K173494OrthoSteady G Bone CementG21 S.r.l.
K172408Biomet Bone Cement RBiomet Inc
K171540Refobacin Bone Cement RBiomet Inc.

Global Unique Device Identification Database

00813478020056Bone Cement
00813478020049Bone Cement
00813478020032Bone Cement
00813478020025Bone Cement
00813478020018Bone Cement
00813478020001Bone Cement
00190446138013BONE CEMENT
00190446138006BONE CEMENT
00190446137993BONE CEMENT
00190446137986BONE CEMENT
00885556646410BONE CEMENT
00885556646403BONE CEMENT
00885556582244BONE CEMENT
00885556582220BONE CEMENT
00885556582213BONE CEMENT

Maude Adverse Events

SMARTSET MV 40G - EODEPUY ORTHOPAEDICS INC US2020-03-31
SMARTSET GHV GENTAMICIN 40GDEPUY CMW - 96109212020-03-31
SMARTSET GHV GENTAMICIN 40GDEPUY CMW - 96109212020-03-31
SMARTSET MV 40G - EODEPUY CMW - 96109212020-03-31
SMARTSET MV 40G - EODEPUY CMW - 96109212020-03-31
PALACOS R 1X40 SINGLEZIMMER BIOMET, INC.2020-03-31
UNKNOWN BONE CEMENTDEPUY CMW - 96109212020-03-31
SMARTSET GMV 40G US EODEPUY CMW - 96109212020-03-31
SMARTSET GMV 40G US EODEPUY CMW - 96109212020-03-31
SMARTSET MV 40G - EODEPUY ORTHOPAEDICS INC US2020-03-31
SMARTSET GMV 40G US EODEPUY ORTHOPAEDICS INC US2020-03-31
UNKNOWN BONE CEMENTDEPUY CMW - 96109212020-03-30
SMARTSET GHV GENTAMICIN 40GDEPUY ORTHOPAEDICS INC US2020-03-30
SMARTSET GHV GENTAMICIN 40GDEPUY ORTHOPAEDICS INC US2020-03-30
UNKNOWN BONE CEMENTDEPUY CMW - 96109212020-03-29
SMARTSET GHV GENTAMICIN 40GDEPUY CMW - 96109212020-03-27
SMARTSET GHV GENTAMICIN 40GDEPUY CMW - 96109212020-03-27
PALACOS RG 1X40 SINGLEZIMMER BIOMET, INC.2020-03-27
BONE CEMENTENCORE MEDICAL L.P.2020-03-27
DEPUY CMW 2G 40GDEPUY CMW - 96109212020-03-27
UNKNOWN BONE CEMENTDEPUY CMW - 96109212020-03-26
UNKNOWN BONE CEMENTDEPUY CMW - 96109212020-03-26
SMARTSET MV ENDURANCE 80GDEPUY ORTHOPAEDICS INC US2020-03-26
UNKNOWN BONE CEMENTDEPUY CMW - 96109212020-03-26
BIOMET BONE CEMENT 2X40GBIOMET FRANCE S.A.R.L.2020-03-26
SMARTSET GHV GENTAMICIN 40GDEPUY CMW - 96109212020-03-25
UNKNOWN BONE CEMENTDEPUY CMW - 96109212020-03-24
SMARTSET GHV GENTAMICIN 40GDEPUY CMW - 96109212020-03-24
UNKNOWN BONE CEMENTDEPUY CMW - 96109212020-03-24
SMARTSET GMV 40G US EODEPUY CMW - 96109212020-03-24
SMARTSET GMV 40G US EODEPUY CMW - 96109212020-03-24
SMARTSET MV 40G - EODEPUY ORTHOPAEDICS INC US2020-03-24
SMARTSET MV 40G - EODEPUY ORTHOPAEDICS INC US2020-03-24
SMARTSET GMV 40G US EODEPUY CMW - 96109212020-03-24
SMARTSET GMV 40G US EODEPUY ORTHOPAEDICS INC US2020-03-24
SMARTSET MV 40G - EODEPUY ORTHOPAEDICS INC US2020-03-24
SMARTSET MV 40G - EODEPUY ORTHOPAEDICS INC US2020-03-24
VERSABOND AB 40 GRAMS F2SMITH & NEPHEW, INC.2020-03-23
SMARTSET MV 40G - EODEPUY CMW - 96109212020-03-23
SMARTSET MV 40G - EODEPUY CMW - 96109212020-03-23
SMARTSET MV 40G - EODEPUY CMW - 96109212020-03-23
SMARTSET MV 40G - EODEPUY CMW - 96109212020-03-23
DEPUY CMW 2 20GDEPUY CMW - 96109212020-03-23
DEPUY CMW 2 20GDEPUY CMW - 96109212020-03-23
DEPUY CMW 2 20GDEPUY CMW - 96109212020-03-23
TRAUMACEM(TM) V+ INJECTABLE BONE CEMENT - STERILEWRIGHTS LANE SYNTHES USA PRODUCTS LLC2020-03-20
UNKNOWN CEMENTZIMMER BIOMET, INC.2020-03-20
UNKNOWN BONE CEMENTDEPUY CMW - 96109212020-03-19
BONE CEMENTENCORE MEDICAL L.P2020-03-19
SMARTSET GHV GENTAMICIN 40GDEPUY CMW - 96109212020-03-18
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