Home GUDID M697T0800100150 Axle Interspinous Fusion System
Primary DI M697T0800100150
Brand Axle Interspinous Fusion System
Company Xtant Medical Holdings, Inc.
Model T080-0100-15
Device description Irix A 6mm Right Angle Up Curette
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 HTF CURETTE
Product Code Classifications# Code, Device, Specialty table Code Device Specialty Class HTF Curette General, Plastic Surgery 1
Identifiers And Packaging# Identifier, Type, Agency table Identifier Type Agency Package quantity Status M697T0800100150 Direct Marking HIBCC 0 M697T0800100151 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.
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 00810168190464 NA PACIFIC INSTRUMENTS, INC. HTF 2026-07-06 B803PS0099100A0 ORTHOMED ORTHO-MED, INC. HTF 2026-06-26 B803PS00991080 ORTHOMED ORTHO-MED, INC. HTF 2026-06-26 B803PS0099108A0 ORTHOMED ORTHO-MED, INC. HTF 2026-06-26 B803PS00991090 ORTHOMED ORTHO-MED, INC. HTF 2026-06-26 B803PS0099109A0 ORTHOMED ORTHO-MED, INC. HTF 2026-06-26 B803PS00991100 ORTHOMED ORTHO-MED, INC. HTF 2026-06-26 B803PS0099110A0 ORTHOMED ORTHO-MED, INC. HTF 2026-06-26 B803PS0395900 ORTHOMED ORTHO-MED, INC. HTF 2026-06-26 B803PS03959000 ORTHOMED ORTHO-MED, INC. HTF 2026-06-26 B803PS039590000 ORTHOMED ORTHO-MED, INC. HTF 2026-06-26 B803PS0395910 ORTHOMED ORTHO-MED, INC. HTF 2026-06-26 B803PS0395920 ORTHOMED ORTHO-MED, INC. HTF 2026-06-26 B803PS0395930 ORTHOMED ORTHO-MED, INC. HTF 2026-06-26 B803PS0395950 ORTHOMED ORTHO-MED, INC. HTF 2026-06-26 B803PS0395960 ORTHOMED ORTHO-MED, INC. HTF 2026-06-26 B803PS0595940 ORTHOMED ORTHO-MED, INC. HTF 2026-06-26 B803PS00991010 ORTHOMED ORTHO-MED, INC. HTF 2026-06-25 B803PS0099101A0 ORTHOMED ORTHO-MED, INC. HTF 2026-06-25 B803PS00991020 ORTHOMED ORTHO-MED, INC. HTF 2026-06-25 B803PS0099102A0 ORTHOMED ORTHO-MED, INC. HTF 2026-06-25 B803PS00991030 ORTHOMED ORTHO-MED, INC. HTF 2026-06-25 B803PS0099103A0 ORTHOMED ORTHO-MED, INC. HTF 2026-06-25 B803PS00991040 ORTHOMED ORTHO-MED, INC. HTF 2026-06-25 B803PS0099104A0 ORTHOMED ORTHO-MED, INC. HTF 2026-06-25 B803PS00991050 ORTHOMED ORTHO-MED, INC. HTF 2026-06-25 B803PS0099105A0 ORTHOMED ORTHO-MED, INC. HTF 2026-06-25 B803PS00991060 ORTHOMED ORTHO-MED, INC. HTF 2026-06-25 B803PS0099106A0 ORTHOMED ORTHO-MED, INC. HTF 2026-06-25 B803PS00991070 ORTHOMED ORTHO-MED, INC. HTF 2026-06-25
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