Home GUDID M719GP3D0828C0 3DP Lumbar Interbody System
Primary DI M719GP3D0828C0
Brand 3DP Lumbar Interbody System
Company Genesys Orthopedics Systems LLC
Model 1
Catalog number GP3D-0828C
Device description 8mm x 28mm Convex 3DP TPLIF
Published 2022-04-20
Public version status Update
Distribution status In Commercial Distribution
MRI safety Labeling does not contain MRI Safety Information
Rx true
Single use true Product Codes# Code, Name table Code Name MAX Intervertebral Fusion Device With Bone Graft, Lumbar
Product Code Classifications# Code, Device, Specialty table Code Device Specialty Class MAX Intervertebral Fusion Device With Bone Graft, Lumbar Orthopedic 2
Identifiers And Packaging# Identifier, Type, Agency table Identifier Type Agency Package quantity Status M719GP3D0828C0 Primary HIBCC 0
GMDN Terms# Term, Definition table Term Definition Metallic spinal interbody fusion cage A device intended to be implanted into the space of an intervertebral disc that has been partially or totally removed during surgery in order to allow bone fusion between two contiguous vertebral bodies, typically in the treatment of degenerative disc disease (DDD). It is in the form of a hollow, porous, threaded and/or fenestrated cylindrical or geometrical device made of metal [e.g., titanium (Ti)] that provides mechanical stability and sufficient space for therapeutic spinal bone fusion to occur; bone graft is typically used to help with osseointegration. Fixation screws and devices associated with implantation may be included with the device.
Device Sizes# Type, Value, Unit table Type Value Unit Height 8 Millimeter Length 28 Millimeter
Sterilization Methods# Method table Method Moist Heat or Steam Sterilization
Regulatory Flags# DUNS number 017921066 Device count 1 Lot or batch true Sterilization required before use true Other Devices From This Company# Other Devices Sharing Product Codes# Primary DI, Brand, Company table Primary DI Brand Company Product code Published 00840606185110 LUNA Ti SPINAL ELEMENTS, INC. MAX 2026-09-25 00840606185127 LUNA Ti SPINAL ELEMENTS, INC. MAX 2026-09-25 00840606185134 LUNA Ti SPINAL ELEMENTS, INC. MAX 2026-09-25 00840606185141 LUNA Ti SPINAL ELEMENTS, INC. MAX 2026-09-25 00840606185158 LUNA Ti SPINAL ELEMENTS, INC. MAX 2026-09-25 00840606185165 LUNA Ti SPINAL ELEMENTS, INC. MAX 2026-09-25 00840606196024 Vertu SPINAL ELEMENTS, INC. MAX 2026-09-25 00840606196031 Vertu SPINAL ELEMENTS, INC. MAX 2026-09-25 00840606196048 Vertu SPINAL ELEMENTS, INC. MAX 2026-09-25 00810017915170 SABER-XA, Screw Ø5.5 x 32.5 ELEVATION SPINE, INC. MAX 2026-09-22 10888857461819 CASCADIA™ Interbody System VB Spine LLC MAX 2019-10-31 10888857461888 CASCADIA™ Interbody System VB Spine LLC MAX 2019-10-31 04546540665720 AVS NAVIGATOR Stryker Corporation MAX 2016-09-24 10888857218772 CASCADIA™ Interbody System VB Spine LLC MAX 2015-12-16 10888857218963 CASCADIA™ Interbody System VB Spine LLC MAX 2015-12-16 10888857219076 CASCADIA™ Interbody System VB Spine LLC MAX 2015-12-16 10888857219489 CASCADIA™ Interbody System VB Spine LLC MAX 2015-12-16 10888857219595 CASCADIA™ Interbody System VB Spine LLC MAX 2015-12-16 07613153046196 AVS PL Stryker Corporation MAX 2015-09-14 07613153046202 AVS PL Stryker Corporation MAX 2015-09-14 07613153046219 AVS PL Stryker Corporation MAX 2015-09-14 07613153046226 AVS PL Stryker Corporation MAX 2015-09-14 07613153046233 AVS PL Stryker Corporation MAX 2015-09-14 07613153046288 AVS PL Stryker Corporation MAX 2015-09-14 07613153046295 AVS PL Stryker Corporation MAX 2015-09-14 07613153046301 AVS PL Stryker Corporation MAX 2015-09-14 07613153046318 AVS PL Stryker Corporation MAX 2015-09-14 07613153046325 AVS PL Stryker Corporation MAX 2015-09-14 07613153046332 AVS PL Stryker Corporation MAX 2015-09-14 07613153046349 AVS PL Stryker Corporation MAX 2015-09-14
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