Home GUDID M697X03409400 Calix Spinal Implant System
Primary DI M697X03409400
Brand Calix Spinal Implant System
Company X-SPINE SYSTEMS, INC.
Model X034-0940
Device description NERVE ROOT RETRACTOR
Published 2015-11-13
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 GAD RETRACTOR
Product Code Classifications# Code, Device, Specialty table Code Device Specialty Class GAD Retractor General, Plastic Surgery 1
Identifiers And Packaging# Identifier, Type, Agency table Identifier Type Agency Package quantity Status M697X03409400 Direct Marking HIBCC 0 M697X03409401 Primary 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.
Sterilization Methods# Method table Method Moist Heat or Steam Sterilization
Regulatory Flags# DUNS number 610042587 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 00190776395483 Millennium Avalign Technologies, Inc. GAD 2026-07-14 B382SD123750 Surgical Direct Surgical Direct, Inc. GAD 2026-07-14 B382SD123760 Surgical Direct Surgical Direct, Inc. GAD 2026-07-14 B382SD123780 Surgical Direct Surgical Direct, Inc. GAD 2026-07-14 B382SD124326191140 Surgical Direct Surgical Direct, Inc. GAD 2026-07-14 B382SD209910FSANT0 Surgical Direct Surgical Direct, Inc. GAD 2026-07-14 B382SD209920FSANT0 Surgical Direct Surgical Direct, Inc. GAD 2026-07-14 B382SD209923FSANT0 Surgical Direct Surgical Direct, Inc. GAD 2026-07-14 B382SD907126105T0 Surgical Direct Surgical Direct, Inc. GAD 2026-07-14 B382SD907247080T0 Surgical Direct Surgical Direct, Inc. GAD 2026-07-14 B382SD907247112T0 Surgical Direct Surgical Direct, Inc. GAD 2026-07-14 B382SD90724711T0 Surgical Direct Surgical Direct, Inc. GAD 2026-07-14 B382SD907249100 Surgical Direct Surgical Direct, Inc. GAD 2026-07-14 B382SD907284670 Surgical Direct Surgical Direct, Inc. GAD 2026-07-14 B382SD907337510 Surgical Direct Surgical Direct, Inc. GAD 2026-07-14 G453152901750 PEAK MEDICAL Peak Medical Distribution Inc. GAD 2026-07-14 00198506091872 ELMED INCORPORATED ELMED INCORPORATED GAD 2026-07-10 00810158211193 PRINCETON Princeton Medical Group, Inc. GAD 2026-07-10 00810158219861 PRINCETON Princeton Medical Group, Inc. GAD 2026-07-10 00888937033687 ONETRAC Coopersurgical, Inc. GAD 2026-07-10 00888937033694 ONETRAC Coopersurgical, Inc. GAD 2026-07-10 00888937033700 ONETRAC Coopersurgical, Inc. GAD 2026-07-10 00888937033717 ONETRAC Coopersurgical, Inc. GAD 2026-07-10 00888937033724 ONETRAC Coopersurgical, Inc. GAD 2026-07-10 00888937033731 ONETRAC LX Coopersurgical, Inc. GAD 2026-07-10 00888937033748 ONETRAC LX Coopersurgical, Inc. GAD 2026-07-10 00888937033755 ONETRAC LX Coopersurgical, Inc. GAD 2026-07-10 00888937033762 ONETRAC LX Coopersurgical, Inc. GAD 2026-07-10 00888937033779 ONETRAC LX Coopersurgical, Inc. GAD 2026-07-10 00888937033786 ONETRAC™ LXS Coopersurgical, Inc. GAD 2026-07-10
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