Home GUDID B7688251170 Stable-L™
Primary DI B7688251170
Brand Stable-L™
Company NEXUS SPINE, L.L.C.
Model 825117
Device description Stable-L Sterile Implant Case
Published 2022-05-31
Public version status New
Distribution status In Commercial Distribution
MRI safety Labeling does not contain MRI Safety Information
Rx true
OTC false
Sterile false
Single use true Product Codes# Code, Name table Code Name MAX Intervertebral Fusion Device With Bone Graft, Lumbar
Product Code Classifications# Code, Device, Specialty table Code Device Specialty Class MAX Intervertebral Fusion Device With Bone Graft, Lumbar Orthopedic 2
Identifiers And Packaging# Identifier, Type, Agency table Identifier Type Agency Package quantity Status B7688251170 Primary HIBCC 0
GMDN Terms# Term, Definition table Term Definition Metallic 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 metal [e.g., titanium (Ti)] 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.
Sterilization Methods# Method table Method Moist Heat or Steam Sterilization
Regulatory Flags# DUNS number 028137605 Device count 1 DM exempt false Premarket exempt false 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 08800043912870 N/A TDM Co., Ltd. MAX 2026-06-02 08800043912887 N/A TDM Co., Ltd. MAX 2026-06-02 08800043912894 N/A TDM Co., Ltd. MAX 2026-06-02 08800043912900 N/A TDM Co., Ltd. MAX 2026-06-02 08800043912917 N/A TDM Co., Ltd. MAX 2026-06-02 08800043912924 N/A TDM Co., Ltd. MAX 2026-06-02 08800043912931 N/A TDM Co., Ltd. MAX 2026-06-02 08800043912948 N/A TDM Co., Ltd. MAX 2026-06-02 08800043912955 N/A TDM Co., Ltd. MAX 2026-06-02 08800043912962 N/A TDM Co., Ltd. MAX 2026-06-02 08800043912979 N/A TDM Co., Ltd. MAX 2026-06-02 08800043912986 N/A TDM Co., Ltd. MAX 2026-06-02 08800043912993 N/A TDM Co., Ltd. MAX 2026-06-02 08800043913006 N/A TDM Co., Ltd. MAX 2026-06-02 08800043913013 N/A TDM Co., Ltd. MAX 2026-06-02 08800043913020 N/A TDM Co., Ltd. MAX 2026-06-02 08800043913037 N/A TDM Co., Ltd. MAX 2026-06-02 08800043913044 N/A TDM Co., Ltd. MAX 2026-06-02 08800043913051 N/A TDM Co., Ltd. MAX 2026-06-02 08800043913068 N/A TDM Co., Ltd. MAX 2026-06-02 08800043913075 N/A TDM Co., Ltd. MAX 2026-06-02 08800043964183 N/A TDM Co., Ltd. MAX 2026-06-02 08800043964190 N/A TDM Co., Ltd. MAX 2026-06-02 08800043964206 N/A TDM Co., Ltd. MAX 2026-06-02 08800043964213 N/A TDM Co., Ltd. MAX 2026-06-02 08800043964220 N/A TDM Co., Ltd. MAX 2026-06-02 08800043964237 N/A TDM Co., Ltd. MAX 2026-06-02 08800043964244 N/A TDM Co., Ltd. MAX 2026-06-02 08800043964251 N/A TDM Co., Ltd. MAX 2026-06-02 08800043964268 N/A TDM Co., Ltd. MAX 2026-06-02