PML

Product Code: PML


Products Classified as PML

4688Bone Cement, Posterior Screw AugmentationPolymethylmethacrylate (PMMA) Bone Cement.

Total Product Life Cycle (TPLC) Devices

4688Bone Cement, Posterior Screw AugmentationPolymethylmethacrylate (PMMA) Bone Cement.

Pre-market Notifications for PML

K222256BonOs® Inject Bone Cement; NEO Pedicle Screw System™Neo Medical SA
K212489BonOs Inject Bone Cement; NEO Pedicle Screw SystemNeo Medical SA
K201362CD Horizon™ Fenestrated Screw Set, CD Horizon™ Spinal System, Kyphon™ HV-R™ Bone CementMedtronic
K192818Vertaplex HV High Viscosity Radiopaque Bone Cement; ES2 Augmentable Spinal SystemStryker Corporation
K191148Medtronic HV-R™ Bone Cement, Kyphon™ Xpede™ Bone Cement, CD Horizon™ Fenestrated Screw SetMedtronic Sofamor Danek, USA Inc.
K190526High V+ Bone Cement, CarboClear® Fenestrated Pedicle ScrewsCarboFix Orthopedics Ltd.
K180498NuVasive Reline Fenestrated Screws, High V+ Bone CementNuVasive, Incorporated
K172269FORTRESS™ Radiopaque Bone Cement (FORTRESS™ And FORTRESS-Plus™), CREO® Fenestrated Screw System, REVLOK® Fenestrated Screw SystemGlobus Medical, Inc.
K171938KYPHON Xpede Bone Cement, CD HORIZON Fenestrated Screw SetMedtronic
K160879CONFIDENCE™ High Viscosity Spinal Cement, VIPER® And EXPEDIUM® Fenestrated Screw SystemsMedos International Sàrl
K152604KYPHON HV-R Fenestrated Screw Cement, CD HORIZON Fenestrated Screw SetMedtronic Sofamor Danek USA, Incorporated

Global Unique Device Identification Database

17290110204485Bone Cement, Posterior Screw Augmentation
17290110204478Bone Cement, Posterior Screw Augmentation
17290110204461Bone Cement, Posterior Screw Augmentation
17290110204454Bone Cement, Posterior Screw Augmentation
17290110204447Bone Cement, Posterior Screw Augmentation
17290110204430Bone Cement, Posterior Screw Augmentation
17290110204423Bone Cement, Posterior Screw Augmentation
17290110204416Bone Cement, Posterior Screw Augmentation
17290110204409Bone Cement, Posterior Screw Augmentation
00887517948373bone cement, posterior screw augmentation
07640164849621Bone Cement, Posterior Screw Augmentation
07640164849614Bone Cement, Posterior Screw Augmentation
07640164849607Bone Cement, Posterior Screw Augmentation
07640164849591Bone Cement, Posterior Screw Augmentation
07640164849584Bone Cement, Posterior Screw Augmentation

Maude Adverse Events

MIS TI CFX FEN POLY 6X45MEDOS INTERNATIONAL SàRL CH2020-01-23
MIS TI CFX FEN POLY 6X30MEDOS INTERNATIONAL SàRL CH2020-01-10
5.5 EXP VERSE FEN SCR 6.0X35MEDOS INTERNATIONAL SàRL CH2020-01-08
MIS TI CFX FEN POLY 6X45MEDOS INTERNATIONAL SàRL CH2019-11-25
5.5 EXP VERSE FEN SCR 4.35X40MEDOS INTERNATIONAL SàRL CH2019-11-14
MIS TI CFX FEN POLY 6X45MEDOS INTERNATIONAL SàRL CH2019-11-01
5.5 EXP VERSE FEN SCR 8.0X40MEDOS INTERNATIONAL SàRL CH2019-10-15
5.5 EXP VERSE FEN SCR 8.0X50MEDOS INTERNATIONAL SàRL CH2019-10-15
5.5 EXP VERSE FEN SCR 8.0X40MEDOS INTERNATIONAL SàRL CH2019-10-15
5.5 EXP VERSE FEN SCR 8.0X50MEDOS INTERNATIONAL SàRL CH2019-10-10
5.5 EXP VERSE FEN SCR 6.0X55MEDOS INTERNATIONAL SàRL CH2019-09-26
5.5 EXP VERSE FEN SCR 6.0X55MEDOS INTERNATIONAL SàRL CH2019-09-26
MIS TI CFX FEN POLY 6X50MEDOS INTERNATIONAL SàRL CH2019-08-20
MIS TI CFX FEN POLY 6X50MEDOS INTERNATIONAL SàRL CH2019-08-20
MIS TI CFX FEN POLY 9X55MEDOS INTERNATIONAL SàRL CH2019-08-01
MIS TI CFX FEN POLY 7X70MEDOS INTERNATIONAL SàRL CH2019-06-11
MIS TI CFX FEN POLY 8X80MEDOS INTERNATIONAL SàRL CH2019-06-11
VIPER PRIME MOD CFXFEN 6X50MEDOS INTERNATIONAL SàRL CH2019-06-07
VIPER PRIME MOD CFXFEN 6X50MEDOS INTERNATIONAL SàRL CH2019-06-07
MIS TI CFX FEN POLY 7X45MEDOS INTERNATIONAL SàRL CH2019-05-21
MIS TI CFX FEN POLY 7X40MEDOS INTERNATIONAL SàRL CH2019-05-20
MIS TI CFX FEN POLY 7X40MEDOS INTERNATIONAL SàRL CH2019-05-20
MIS TI CFX FEN POLY 7X40MEDOS INTERNATIONAL SàRL CH2019-05-20
MIS TI CFX FEN POLY 7X50MEDOS INTERNATIONAL SàRL CH2019-05-20
MIS TI CFX FEN POLY 7X40MEDOS INTERNATIONAL SàRL CH2019-05-20
MIS TI CFX FEN POLY 8X40MEDOS INTERNATIONAL SàRL CH2019-05-17
MIS TI CFX FEN POLY 7X40MEDOS INTERNATIONAL SàRL CH2019-05-17
MIS TI CFX FEN POLY 7X40MEDOS INTERNATIONAL SàRL CH2019-05-17
MIS TI CFX FEN POLY 6X40MEDOS INTERNATIONAL SàRL CH2019-05-17
MIS TI CFX FEN POLY 7X45MEDOS INTERNATIONAL SàRL CH2019-04-26
MIS TI CFX FEN POLY 10X80MEDOS INTERNATIONAL SàRL CH2019-04-05
5.5 EXP VERSE FEN SCR 8.0X50MEDOS INTERNATIONAL SàRL CH2019-03-28
MIS TI CFX FEN POLY 7X65MEDOS INTERNATIONAL SàRL CH2019-03-13
5.5 EXP VERSE FEN SCR 6.0X50MEDOS INTERNATIONAL SàRL CH2019-02-12
5.5 EXP VERSE FEN SCR 7.0X45MEDOS INTERNATIONAL SàRL CH2019-02-12
5.5 EXP VERSE FEN SCR 7.0X40MEDOS INTERNATIONAL SàRL CH2019-02-12
5.5 EXP VERSE FEN SCR 7.0X45MEDOS INTERNATIONAL SàRL CH2019-02-12
MIS TI CFX FEN POLY 7X40MEDOS INTERNATIONAL SàRL CH2018-12-21
5.5 EXP VERSE FEN SCR 6.0X45MEDOS INTERNATIONAL SàRL CH2018-12-20
MIS TI CFX FEN POLY 9X80MEDOS INTERNATIONAL SàRL CH2018-12-20
5.5 EXP VERSE FEN SCR 6.0X45MEDOS INTERNATIONAL SàRL CH2018-12-20
MIS TI CFX FEN POLY 9X80MEDOS INTERNATIONAL SàRL CH2018-12-20
MIS TI CFX FEN POLY 7X40MEDOS INTERNATIONAL SàRL CH2018-12-04
MIS TI CFX FEN POLY 7X45MEDOS INTERNATIONAL SàRL CH2018-11-15
MIS TI CFX FEN POLY 7X50MEDOS INTERNATIONAL SàRL CH2018-11-05
5.5 EXP VERSE FEN SCR 7.0X60MEDOS INTERNATIONAL SàRL CH2018-10-23
MIS TI CFX FEN POLY 7X50MEDOS INTERNATIONAL SàRL CH2018-10-10
MIS TI CFX FEN POLY 7X50MEDOS INTERNATIONAL SàRL CH2018-10-10
MIS TI CFX FEN POLY 7X45MEDOS INTERNATIONAL SàRL CH2018-10-01
MIS TI CFX FEN POLY 8X55MEDOS INTERNATIONAL SàRL CH2018-09-06

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