Home GUDID M697T080010020 Axle Interspinous Fusion System
Primary DI M697T080010020
Brand Axle Interspinous Fusion System
Company Xtant Medical Holdings, Inc.
Model T080-0100-2
Device description Irix A 20mm Elevator
Published 2015-10-30
Public version status Update
Distribution status In Commercial Distribution
MRI safety Labeling does not contain MRI Safety Information
Rx true
OTC false
Sterile false
Single use false Product Codes# Code, Name table Code Name HTE ELEVATOR
Product Code Classifications# Code, Device, Specialty table Code Device Specialty Class HTE Elevator General, Plastic Surgery 1
Identifiers And Packaging# Identifier, Type, Agency table Identifier Type Agency Package quantity Status M697T080010020 Direct Marking HIBCC 0 M697T080010021 Primary HIBCC 0
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 Width 20 Millimeter
Sterilization Methods# Method table Method Moist Heat or Steam Sterilization
Regulatory Flags# DUNS number 081224143 Device count 1 DM exempt false Premarket exempt true HCT/P false Kit false Combination product false Lot or batch true Serial number false Manufacturing date on label false Expiration date on label false Donation ID number false Contains natural rubber latex false No natural rubber latex false 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 10705034579580 N/A Medos International Sàrl HTE 2026-06-25 10705034579597 N/A Medos International Sàrl HTE 2026-06-25 10705034579603 N/A Medos International Sàrl HTE 2026-06-25 B8039702640 ORTHOMED ORTHO-MED, INC. HTE 2026-06-22 09348811078988 INKA The Trustee for KAISER FAMILY TRUST HTE 2026-03-18 10840199507723 Separator KOROS U.S.A., INC. HTE 2024-12-31 10840199507730 Separator KOROS U.S.A., INC. HTE 2024-12-31 10840199507747 Elevator KOROS U.S.A., INC. HTE 2024-12-31 10840199507754 Elevator KOROS U.S.A., INC. HTE 2024-12-31 10840199507761 Elevator KOROS U.S.A., INC. HTE 2024-12-31 10840199507778 Elevator KOROS U.S.A., INC. HTE 2024-12-31 10840199507785 Elevator KOROS U.S.A., INC. HTE 2024-12-31 10840199507792 Elevator KOROS U.S.A., INC. HTE 2024-12-31 10840199507808 Elevator KOROS U.S.A., INC. HTE 2024-12-31 10840199507815 Elevator KOROS U.S.A., INC. HTE 2024-12-31 10840199507877 Elevator KOROS U.S.A., INC. HTE 2024-12-31 10840199507969 Elevator KOROS U.S.A., INC. HTE 2024-12-31 10840199511447 Elevator KOROS U.S.A., INC. HTE 2024-12-31 10840199511454 Elevator KOROS U.S.A., INC. HTE 2024-12-31 10840199526540 Elevator KOROS U.S.A., INC. HTE 2024-12-31 10840199526557 Elevator KOROS U.S.A., INC. HTE 2024-12-31 10840199545558 Elevator KOROS U.S.A., INC. HTE 2024-02-05 10840199527288 Elevator KOROS U.S.A., INC. HTE 2024-01-31 10840199527295 Elevator KOROS U.S.A., INC. HTE 2024-01-31 10840199527301 Elevator KOROS U.S.A., INC. HTE 2024-01-31 10840199527318 Elevator KOROS U.S.A., INC. HTE 2024-01-31 10840199527325 Elevator KOROS U.S.A., INC. HTE 2024-01-31 10840199527332 Elevator KOROS U.S.A., INC. HTE 2024-01-31 10840199527349 Elevator KOROS U.S.A., INC. HTE 2024-01-31 10840199527356 Elevator KOROS U.S.A., INC. HTE 2024-01-31
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