Home GUDID M697X06003900 Axle Interspinous Fusion System
Primary DI M697X06003900
Brand Axle Interspinous Fusion System
Company Xtant Medical Holdings, Inc.
Model X060-0390
Device description Spreader, Axle System
Published 2015-05-26
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 GDI DISSECTOR, SURGICAL, GENERAL & PLASTIC SURGERY
Product Code Classifications# Code, Device, Specialty table Code Device Specialty Class GDI Dissector, Surgical, General & Plastic Surgery General, Plastic Surgery 1
Identifiers And Packaging# Identifier, Type, Agency table Identifier Type Agency Package quantity Status M697X06003900 Direct Marking HIBCC 0 M697X06003901 Primary HIBCC 0
GMDN Terms# Term, Definition table Term Definition Lumbar interspinous decompression instrument set, reusable A collection of surgical instruments and devices intended to be used for the implantation of an interspinous process decompression (IPD) implant that is inserted between two adjacent lumbar spinous processes during a minimally-invasive procedure to decompress neural structures; this is typically to treat a patient suffering from symptomatic degenerative lumbar spinal stenosis (DLSS). It typically consists of a tray, dedicated dilators, a sizing instrument, a spacer (the implant) insertion instrument, implant holders, and a torque-limiting screwdriver. This is a reusable 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 00810068850765 Biocore9 Acetabular Bearing System Biocore9, LLC GDI 2026-06-26 07898789390121 ENDOFOREHEAD DISSECTOR 5MM ANGLED TOYO COMERCIO IMPORTACAO E EXPORTACAO DE INSTRUMENTOS CIRURGICOS LTDA GDI 2026-06-09 07898789390138 ENDOFOREHEAD DISSECTOR WITH SUCTION STRAIGHT 30CM TOYO COMERCIO IMPORTACAO E EXPORTACAO DE INSTRUMENTOS CIRURGICOS LTDA GDI 2026-06-09 07898789390039 GRAIVIER MID-FACE DISSECTOR LEFT TOYO COMERCIO IMPORTACAO E EXPORTACAO DE INSTRUMENTOS CIRURGICOS LTDA GDI 2026-03-25 07898789390046 GRAIVIER MID-FACE DISSECTOR RIGHT TOYO COMERCIO IMPORTACAO E EXPORTACAO DE INSTRUMENTOS CIRURGICOS LTDA GDI 2026-03-25 07898789390060 FRONTO MARTINS 2 ENDOFOREHEAD DISSECTOR TOYO COMERCIO IMPORTACAO E EXPORTACAO DE INSTRUMENTOS CIRURGICOS LTDA GDI 2026-03-25 00196449034512 Anatomic Access LLIF Tyber Medical, LLC GDI 2025-10-22 06971503600209 comknife® Beijing Bohai Kangyuan Medical Devices Co., Ltd. GDI 2025-08-28 06971503600216 comknife® Beijing Bohai Kangyuan Medical Devices Co., Ltd. GDI 2025-08-28 06971503602951 comknife® Beijing Bohai Kangyuan Medical Devices Co., Ltd. GDI 2025-08-28 06971503602968 comknife® Beijing Bohai Kangyuan Medical Devices Co., Ltd. GDI 2025-08-28 06971503602975 comknife® Beijing Bohai Kangyuan Medical Devices Co., Ltd. GDI 2025-08-28 06971503602982 comknife® Beijing Bohai Kangyuan Medical Devices Co., Ltd. GDI 2025-08-28 06971503602999 comknife® Beijing Bohai Kangyuan Medical Devices Co., Ltd. GDI 2025-08-28 06971503603941 comknife® Beijing Bohai Kangyuan Medical Devices Co., Ltd. GDI 2025-08-28 06971503603958 comknife® Beijing Bohai Kangyuan Medical Devices Co., Ltd. GDI 2025-08-28 00841732129337 GENERIC Surgical Instruments CTL Medical Corporation GDI 2025-06-04 00840183523046 BR Surgical, LLC BR Surgical, LLC GDI 2024-03-06 00850036790013 Aveli Revelle Aesthetics, Inc. GDI 2024-02-26 10840199523402 Dissector KOROS U.S.A., INC. GDI 2024-02-06 10840199533302 Dissector KOROS U.S.A., INC. GDI 2024-02-06 10840199533319 Dissector KOROS U.S.A., INC. GDI 2024-02-06 10840199533326 Dissector KOROS U.S.A., INC. GDI 2024-02-06 10840199533357 Dissector KOROS U.S.A., INC. GDI 2024-02-06 10840199533364 Dissector KOROS U.S.A., INC. GDI 2024-02-06 10840199533371 Dissector KOROS U.S.A., INC. GDI 2024-02-06 10840199533449 Dissector KOROS U.S.A., INC. GDI 2024-02-06 10840199533456 Dissector KOROS U.S.A., INC. GDI 2024-02-06 10840199533463 Dissector KOROS U.S.A., INC. GDI 2024-02-06 10840199533470 Dissector KOROS U.S.A., INC. GDI 2024-02-06
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