FDA.reportPublic FDA data

Vertebral bone filler, non-bioabsorbable

Definition
A sterile substance intended to be used to replace cortical/cancellous bone in a vertebral body to stabilize vertebral compression fractures (VCFs) caused by cancer, osteoporosis, or trauma. The device may be a sterile powder of a synthetic polymer [e.g., polymethylmethacrylate (PMMA)] that is mixed with its sterile diluent, or a non-PMMA-containing elastomer formed by mixing two precursors, prior to implantation typically during a balloon kyphoplasty or vertebroplasty procedure. This device does not contain an antibiotic agent. After application, this device cannot be reused.
GUDID devices
45
Last updated
2026-10-04 01:44:39

Representative GUDID Devices#

Primary DI, Brand, Company table
Primary DIBrandCompanyModelPublished
00808232000962CortossStryker Corporation2101-00052015-09-24
00808232000979CortossStryker Corporation2101-00102015-09-24
07613327170559VertaPlex HVSTRYKER CORPORATION04066220152016-09-23
04546540434364SpinePlexSTRYKER CORPORATION04062020002016-06-30
07613252254430VertaPlexSTRYKER CORPORATION04066220002016-09-23
07613327141788SpinePlexSTRYKER CORPORATION04062020102016-09-23
03760177041080SINPLUS STEKNIMED80052015-10-16
03760177041677KYPHON ACTIVOS 10TEKNIMEDC10A2015-10-16
03760177042384SPINE-FIX USTEKNIMEDUS040320S2015-10-16
03760177043060ZVplastyTEKNIMEDVCF-10092015-10-16
03760177043923COHESIONTEKNIMEDCM03002015-10-16
03760177043930VERTEFIXTEKNIMEDVBC-1002015-10-16
03760177043954VERTEMENDTEKNIMED66-VMD-1002015-10-16
07613154757091VertaPlexSTRYKER CORPORATION04064020002016-06-30
07613327141764VertaPlexSTRYKER CORPORATION04064020022016-09-23
07613327170566VertaPlexSTRYKER CORPORATION04064020152016-09-23
08057432566149SINPLUS SSINTEA PLUSTEK SRL80052016-01-19
08809544171557MVX PlusIMEDICOM CO., LTD.MVX-P2017-04-10
08809544171564MVX USIMEDICOM CO., LTD.MVX-012017-04-10
03701505801204DynamoTEKNIMEDSpinal Cement – MV2026-02-02
03760177040113OPACITY +TEKNIMEDT040320Z2015-10-16
03760177041110F20TEKNIMEDT0405202015-10-16
03760177041721HIGH V+TEKNIMEDT0403212017-08-22
03760177042391EXOFIXTEKNIMEDT0403232015-10-16
03701505800528Invictus® Bone CementTEKNIMED17095-1-S2023-02-17
03760177047174META +TEKNIMEDT0403522022-09-12
03760177049420INTROX® HighV TEKNIMEDSM-IN3001C2021-01-25
03760177046344CONFIDENCETEKNIMED11 CC2020-11-25
03760177046528KYPHON ACTIVOS 10TEKNIMEDC10A2020-11-25
03760177047419NuVasive Maximum Viscosity CementTEKNIMEDNuVasive Maximum Viscosity Cement2020-11-23
03760177046351OSTEOFLEXTEKNIMEDVCF-10092020-10-21
03760177043947CONFIDENCETEKNIMED11 CC2015-10-16
03760177042933OSTEOFLEXTEKNIMEDINTV-CEM2015-10-16
00815212023439VERTEFIX Plus USTEKNIMEDVBC-100-PL-US2020-09-24
03760177046276OsteofixTEKNIMEDG90000/VBC-2002020-09-25
03760177046320OSTEOFLEXTEKNIMEDVCF-10092020-09-25
03760177046368OSTEOFLEX LV TEKNIMEDINTV-CEMLV2020-09-24
03760177046399MVX-PLUSTEKNIMEDMVX-P2020-09-25
03760177046283ThermalfixTEKNIMEDG90001/VBC-3002020-09-24
03760177046313Synth-X SLTEKNIMEDHC-SX-SL2020-09-24
03760177046337OSSEOFIX +TEKNIMED213902015-10-16
04260056880759Vertecem II Cement KitOSARTIS GmbH08.702.017S2015-10-21
04260056883231BonOs InjectOSARTIS GmbH01-03092015-10-02
00844856032231Osseofix +ALPHATEC SPINE, INC.213902016-10-28
00376017704882Osseofix +ALPHATEC SPINE, INC.213902016-04-14