Home GUDID 03662663012010 ROI-A
Primary DI 03662663012010
Brand ROI-A
Company LDR Spine Usa, Inc.
Model IR2741P
Device description ROI-A MEDIAN IMPLANT PXL33X36 H14 14°
Published 2015-10-24
Public version status Update
Distribution status In Commercial Distribution
MRI safety MR Conditional
Rx true
Sterile true
Single use true Product Codes# Code, Name table Code Name MAX Intervertebral Fusion Device With Bone Graft, Lumbar MQP Spinal Vertebral Body Replacement Device OVD Intervertebral Fusion Device With Integrated Fixation, Lumbar
Product Code Classifications# Code, Device, Specialty table Code Device Specialty Class MAX Intervertebral Fusion Device With Bone Graft, Lumbar Orthopedic 2 MQP Spinal Vertebral Body Replacement Device Orthopedic 2 OVD Intervertebral Fusion Device With Integrated Fixation, Lumbar Orthopedic 2
Identifiers And Packaging# Identifier, Type, Agency table Identifier Type Agency Package quantity Status 03662663012010 Primary GS1 0
Alternate GTIN / UPC / EAN Codes Source identifier, GTIN-14 normalized, EAN-13 table Source identifier GTIN-14 normalized EAN-13 03662663012010 03662663012010 3662663012010
GMDN Terms# Term, Definition table Term Definition Polymeric spinal fusion cage, sterile A sterile device intended to help fuse segments of the spine to treat anatomical abnormalities of the vertebrae, typically due to degenerative intervertebral disks [i.e., degenerative disc disease (DDD)]. The device is typically designed as a small, hollow and/or porous, threaded or fenestrated cylinder (or other geometric form) and is made of non-bioabsorbable synthetic polymer [e.g., polyetheretherketone (PEEK)] that is implanted between the bones or bone grafts of the spine, to provide mechanical stability and sufficient space for bone fusion to occur. Fixation screws and disposable devices associated with implantation may be included with the device.
Device Sizes# Type, Value, Unit table Type Value Unit Angle 14 degree Depth 33 Millimeter Height 14 Millimeter Width 36 Millimeter
Regulatory Flags# DUNS number 615789729 Device count 1 Lot or batch true Expiration date on label true Other Devices From This Company# Other Devices Sharing Product Codes# Primary DI, Brand, Company table Primary DI Brand Company Product code Published M719GLL100QC0 3DP Lumbar Interbody System Genesys Orthopedics Systems LLC MAX 2026-07-14 M719GLL101QC0 3DP Lumbar Interbody System Genesys Orthopedics Systems LLC MAX 2026-07-14 M719GLL106QC0 3DP Lumbar Interbody System Genesys Orthopedics Systems LLC MAX 2026-07-14 M719GLL107QC0 3DP Lumbar Interbody System Genesys Orthopedics Systems LLC MAX 2026-07-14 00763000857820 T2 STRATOSPHERE™ Expandable Corpectomy System MEDTRONIC SOFAMOR DANEK, INC. MQP 2026-06-26 00763000858001 T2 STRATOSPHERE™ Expandable Corpectomy System MEDTRONIC SOFAMOR DANEK, INC. MQP 2026-06-26 08800043913099 N/A TDM Co., Ltd. MAX 2026-06-10 08800043913105 N/A TDM Co., Ltd. MAX 2026-06-10 08800043913112 N/A TDM Co., Ltd. MAX 2026-06-10 08800043913129 N/A TDM Co., Ltd. MAX 2026-06-10 08800043913136 N/A TDM Co., Ltd. MAX 2026-06-10 08800043913143 N/A TDM Co., Ltd. MAX 2026-06-10 08800043913150 N/A TDM Co., Ltd. MAX 2026-06-10 08800043913167 N/A TDM Co., Ltd. MAX 2026-06-10 08800043913174 N/A TDM Co., Ltd. MAX 2026-06-10 08800043913181 N/A TDM Co., Ltd. MAX 2026-06-10 08800043913198 N/A TDM Co., Ltd. MAX 2026-06-10 08800043913204 N/A TDM Co., Ltd. MAX 2026-06-10 08800043913211 N/A TDM Co., Ltd. MAX 2026-06-10 08800043917288 N/A TDM Co., Ltd. MAX 2026-06-10 08800043917295 N/A TDM Co., Ltd. MAX 2026-06-10 08800043917301 N/A TDM Co., Ltd. MAX 2026-06-10 08800043917318 N/A TDM Co., Ltd. MAX 2026-06-10 08800043917325 N/A TDM Co., Ltd. MAX 2026-06-10 08800043917332 N/A TDM Co., Ltd. MAX 2026-06-10 08800043917349 N/A TDM Co., Ltd. MAX 2026-06-10 08800043967177 N/A TDM Co., Ltd. MAX 2026-06-10 08800043967184 N/A TDM Co., Ltd. MAX 2026-06-10 08800043967191 N/A TDM Co., Ltd. MAX 2026-06-10 08800043967207 N/A TDM Co., Ltd. MAX 2026-06-10
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