Product Code: MBB


Products Classified as MBB

4614Bone Cement, AntibioticPolymethylmethacrylate (PMMA) Bone Cement.

Total Product Life Cycle (TPLC) Devices

4614Bone Cement, AntibioticPolymethylmethacrylate (PMMA) Bone Cement.

FDA Consensus Standards

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

Pre-market Notifications for MBB

K221968StageOneâ„¢ Shoulder Cement Spacer MoldsBiomet, Inc.
K213287StageOne Knee Cement Spacer MoldsBiomet, Inc.
K202338SpaceFlex ShoulderG21 Srl
K201960SpaceFlex Knee - 80mm SizeG21 S.r.l
K192041G21 SpaceFlex HipG21 S.r.l
K190216SpaceFlex KneeG21 S.R.L
K161273StageOne Disposable Cement Spacer Molds For Temporary Knee ProsthesisBiomet, Inc.
K161166StageOne Select Cement Spacer Molds For Temporary Hip ReplacementBIOMET, INC.
K160071StageOne Disposable Cement Spacer Molds For Temporary Hemi-Shoulder ProsthesisBiomet, Inc.
K150850Refobacin Bone Cement RBIOMET, INC.
K131135BIOMET STAGE ONE DISPOSABLE CEMENT SPACER MOLDS FOR TEMPORARY HEMI-SHOULDER PROSTHESISBIOMET MANUFACTURING CORP.
K081163SMARTSET GMV GENTAMICIN BONE CEMENTDEPUY ORTHOPAEDICS, INC.
K063857SIMPLEX P SPEEDSET WITH TOBRAMYCIN BONE CEMENTHOWMEDICA OSTEONICS CORP.
K061144DEPUY CMW 2 AND CMW 3 GENTAMICIN BONE CEMENTDEPUY ORTHOPAEDICS, INC.
K053002DEPUY CMW 1 GENTAMICIN BONE CEMENTDEPUY ORTHOPAEDICS, INC.

Global Unique Device Identification Database

00822409007585BONE CEMENT, ANTIBIOTIC
00822409007561BONE CEMENT, ANTIBIOTIC
00885556582268BONE CEMENT, ANTIBIOTIC
00885556582251BONE CEMENT, ANTIBIOTIC
00885556582237BONE CEMENT, ANTIBIOTIC
00880304990227BONE CEMENT, ANTIBIOTIC
00880304990197BONE CEMENT, ANTIBIOTIC
00880304476783Bone Cement, Antibiotic
00855195006616Bone Cement, Antibiotic
00855195006500Bone Cement, Antibiotic
00855195006494Bone Cement, Antibiotic
00855195006487Bone Cement, Antibiotic
00855195006470Bone Cement, Antibiotic
00855195006463Bone Cement, Antibiotic
00855195006456Bone Cement, Antibiotic

Maude Adverse Events

DEPUY/CMW 2GDEPUY CMW - 96109212020-03-13
DEPUY/CMW 2GDEPUY CMW - 96109212020-03-13
DEPUY/CMW 2GDEPUY CMW - 96109212020-03-13
REFOBACIN BONE CEMENT R 2X40GBIOMET FRANCE S.A.R.L.2020-03-11
REFOBACIN PLUS BONE CEMENT 40X2BIOMET FRANCE S.A.R.L.2020-03-06
OPTIPAC 40 REFOBACIN BONE CEMENT R-3BIOMET FRANCE S.A.R.L.2020-03-05
DEPUY/CMW 2GDEPUY CMW - 96109212020-03-03
DEPUY/CMW 2GDEPUY CMW - 96109212020-03-03
REFOBACIN BC R 1X40 USBIOMET FRANCE S.A.R.L.2020-03-02
OPTIPAC 40 REFOBACIN BONE CEMENT RBIOMET FRANCE S.A.R.L.2020-02-27
REFOBACIN BONE CEMENT R 1X40GBIOMET FRANCE S.A.R.L.2020-02-18
REFOBACIN BONE CEMENT R 1X40GBIOMET FRANCE S.A.R.L.2020-02-07
REFOBACIN BONE CEMENT R 1X40GBIOMET FRANCE S.A.R.L.2020-02-05
DEPUY/CMW 2GDEPUY CMW - 96109212020-01-30
REFOBACIN BONE CEMENT R 1X40GBIOMET FRANCE S.A.R.L.2020-01-28
REFOBACIN BONE CEMENT R 1X40GBIOMET FRANCE S.A.R.L.2020-01-28
REFOBACIN BONE CEMENT R 1X40GBIOMET FRANCE S.A.R.L.2020-01-28
PALACOS R+ G SING DOSE 40 GRZIMMER, INC.2020-01-16
PROSTALAC MOLD SZ3 240 LTDEPUY ORTHOPAEDICS INC US2020-01-16
PROSTALAC MOLD SZ3 240 LTDEPUY ORTHOPAEDICS INC US2020-01-15
PROSTALAC MOLD SZ3 240 LTDEPUY ORTHOPAEDICS INC US2020-01-15
DEPUY/CMW 2GDEPUY ORTHOPAEDICS, INC. 18189102020-01-13
DEPUY/CMW 2GDEPUY ORTHOPAEDICS, INC. 18189102020-01-13
DEPUY/CMW 2GDEPUY ORTHOPAEDICS, INC. 18189102020-01-13
REFOBACIN BONE CEMENT R 1X40GBIOMET FRANCE S.A.R.L.2020-01-10
PROSTALAC MOLD SZ3 240 LTDEPUY ORTHOPAEDICS INC US2020-01-09
DEPUY/CMW 2GDEPUY CMW - 96109212020-01-09
DEPUY/CMW 2GDEPUY CMW - 96109212020-01-09
OPTIPAC-S 60 REFOBACIN BONE CEMENT RBIOMET FRANCE S.A.R.L.2020-01-09
OPTIPAC 60 REFOBACIN BONE CEMENT RBIOMET FRANCE S.A.R.L.2020-01-08
DEPUY/CMW 2GDEPUY CMW - 96109212020-01-03
DEPUY/CMW 2GDEPUY CMW - 96109212020-01-03
REFOBACIN BC R 1X40 USBIOMET FRANCE S.A.R.L.2020-01-02
REFOBACIN BC R 1X40 USBIOMET FRANCE S.A.R.L.2020-01-02
REFOBACIN BONE CEMENT R 1X40GBIOMET FRANCE S.A.R.L.2020-01-02
REFOBACIN BONE CEMENT R 1X40GBIOMET FRANCE S.A.R.L.2020-01-02
REFOBACIN REVISION 1X40GBIOMET FRANCE S.A.R.L.2019-12-31
REFOBACIN BONE CEMENT R 1X40GBIOMET FRANCE S.A.R.L.2019-12-23
REFOBACIN BONE CEMENT R 1X40GBIOMET FRANCE S.A.R.L.2019-12-16
REFOBACIN BONE CEMENT R 1X40GBIOMET FRANCE S.A.R.L.2019-12-09
REFOBACIN BONE CEMENT R 1X40GBIOMET FRANCE S.A.R.L.2019-12-06
REFOBACIN BONE CEMENT R 1X40GBIOMET FRANCE S.A.R.L.2019-12-06
REFOBACIN BONE CEMENT R 1X40GBIOMET FRANCE S.A.R.L.2019-12-06
REFOBACIN BONE CEMENT R 1X40GBIOMET FRANCE S.A.R.L.2019-12-04
REFOBACIN BONE CEMENT R 1X40GBIOMET FRANCE S.A.R.L.2019-11-29
REFOBACIN BONE CEMENT R 1X40GBIOMET FRANCE S.A.R.L.2019-11-29
REFOBACIN BONE CEMENT R 1X40GBIOMET FRANCE S.A.R.L.2019-11-29
REFOBACIN BONE CEMENT R 1X40GBIOMET FRANCE S.A.R.L.2019-11-29
REFOBACIN BONE CEMENT R 1X40GBIOMET FRANCE S.A.R.L.2019-11-28
REFOBACIN BONE CEMENT R 1X40GBIOMET FRANCE S.A.R.L.2019-11-28

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