System

Columbia System

GENERIC NAME: ANTERIOR THORACOLUMBAR FIXATION SYSTEM

COMMERCIAL NAME: COLUMBIA

REFERENCE: 104

MANUFACTURER: Mediimplantes S.A.

MANUFACTURING MATERIAL: Ti 6Al 4V ELI (Extra low interstitial) Alloy for Surgical Implant Applications – UNS R56401, ASTM F136-02.

FUNCTIONAL DESCRIPTION

COLUMBIA is a system designed to be used in thoracic and thoracolumbar spine segments. The system’s plaques and screws are available in different sizes. Screw size selection must be done taking vertebral body size into account, with the purpose of achieving superior stability.
The surgeon has the option to build a system that combines a low profile with an auto-locking mechanism.

INDICATIONS

Pseudarthrosis, severe degenerative discopathies, tumors and infections, where total or partial corpectomy is performed at thoracic and/or lumbar levels.

CERTIFICATES

-ISO 9001 / ISO 13485 Certifications

-INVIMA SANITARY REGISTRATION 2018DM-0000665R1

PRESENTATION AND PACKAGING

Implants from the COLUMBIA System are provided unsterilized, individually packaged, and individually laser-marked. Each laser marking shows: product code, lot number,
MEDIIMPLANTES logo, material symbol (Ti), and use-specific dimensions. Laser markings are permanent and allow for product traceability, even after implantation.

Primary Packaging: medical-grade paper bag for products to be sterilized and a laminated polyester film with a security band. It’s provided with non-toxic chemical indicators, fit for commercial sterilization methods, allowing for internal monitoring of sterilization parameters.

Secondary Packaging: Organizing racks that protect the implant from any possible mechanical damage caused by product movement to other locations.

Tertiary Packaging: Aluminum cases with safety mechanisms that contain all available organizing racks to display in an organized fashion for the surgeon’s use.

STORAGE AND AVAILABILITY

Immediate availability and easy storage. Does not need refrigeration nor any special handling procedures asides from maintaining cleanliness conditions to guarantee sterilization.

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