Home GUDID M697T06609521 Irix-C Cervical Integrated Fusion System
Primary DI M697T06609521
Brand Irix-C Cervical Integrated Fusion System
Company Xtant Medical Holdings, Inc.
Model T066-0952
Device description Distraction Screw, 16 mm
Published 2018-01-10
Public version status Update
Distribution status In Commercial Distribution
MRI safety Labeling does not contain MRI Safety Information Product Codes# Code, Name table Code Name GDF GUIDE, NEEDLE, SURGICAL
Product Code Classifications# Code, Device, Specialty table Code Device Specialty Class GDF Guide, Needle, Surgical General, Plastic Surgery 1
Identifiers And Packaging# Identifier, Type, Agency table Identifier Type Agency Package quantity Status M697T06609521 Primary HIBCC 0 M697T06609522 Unit of Use HIBCC 0
GMDN Terms# Term, Definition table Term Definition Polymeric 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 non-bioabsorbable synthetic polymer [e.g., polyetheretherketone (PEEK)] 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 Length 16 Millimeter
Sterilization Methods# Method table Method Ethylene Oxide
Regulatory Flags# DUNS number 081224143 Device count 5 DM exempt true Premarket exempt true Lot or batch true Expiration date on label 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 06976712970334 Hemo Needle Micro-Energy Medical Technology Co., Ltd GDF 2026-07-13 04048223069738 TunnEler 235 Pajunk GmbH Medizintechnologie GDF 2026-06-10 10197344044795 MEDLINE MEDLINE INDUSTRIES, INC. GDF 2025-09-23 10197344044801 MEDLINE MEDLINE INDUSTRIES, INC. GDF 2025-09-23 ESAM14762481 STOMA® Storz am Mark GmbH GDF 2025-04-30 07630037864523 APTUS Medartis AG GDF 2025-04-08 07630037864547 APTUS Medartis AG GDF 2025-04-08 07630037864561 APTUS Medartis AG GDF 2025-04-08 07630037864585 APTUS Medartis AG GDF 2025-04-08 10197106342312 CARDINAL HEALTH Cardinal Health 200, LLC GDF 2024-04-01 07630037864165 APTUS Medartis AG GDF 2024-03-22 ESAM14755481 STOMA® Storz am Mark GmbH GDF 2023-11-20 ESAM14760481 STOMA® Storz am Mark GmbH GDF 2023-06-05 ESAM14761481 STOMA® Storz am Mark GmbH GDF 2023-06-05 ESAM14750481 STOMA® Storz am Mark GmbH GDF 2022-11-07 ESAM14751481 STOMA® Storz am Mark GmbH GDF 2022-11-07 08033860028596 BIOPSYBELL BIOPSYBELL SRL GDF 2022-09-16 08033860028602 BIOPSYBELL BIOPSYBELL SRL GDF 2022-09-16 08033860030353 BIOPSYBELL BIOPSYBELL SRL GDF 2022-09-16 10840199534132 Needle Holder KOROS U.S.A., INC. GDF 2022-08-01 10840199534149 Needle Holder KOROS U.S.A., INC. GDF 2022-08-01 10840199534156 Needle Holder KOROS U.S.A., INC. GDF 2022-08-01 10840199534163 Needle Holder KOROS U.S.A., INC. GDF 2022-08-01 10840199534170 Needle Holder KOROS U.S.A., INC. GDF 2022-08-01 10840199534187 Needle Holder KOROS U.S.A., INC. GDF 2022-08-01 10840199534194 Needle Holder KOROS U.S.A., INC. GDF 2022-08-01 10840199534200 Needle Holder KOROS U.S.A., INC. GDF 2022-08-01 10840199534217 Needle Holder KOROS U.S.A., INC. GDF 2022-08-01 10840199534224 Needle Holder KOROS U.S.A., INC. GDF 2022-08-01 10840199534231 Needle Holder KOROS U.S.A., INC. GDF 2022-08-01
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