System

ELITE TLIF

GENERIC NAME: MEDIIMPLANTES LUMBAR TRANSFORAMINAL INTERBODY FUSION SYSTEM – ELITE TLIF.

COMMERCIAL NAME: ELITE TLIF SYSTEM

REFERENCE: 11

MANUFACTURER: Mediimplantes SA.

FABRICATION MATERIAL:

* PEEK – Polyether-ether-ketone polymer (PEEK-OPTIMA® LT1 R20), suitable for surgical implant manufacturing according the ASTM F2026 norm.

* Tantalum: suitable material for surgical implant applications in compliance with ISO 13782 and ASTM F560 norms.

FUNCTIONAL DESCRIPTION

The ELITE TLIF is a system based on the surgical technique known as TLIF (Transforaminal Lumbar Interbody Fusion). It consists of TLIF fusion cases made of PEEK, which are inactive, single-use surgical implants available in different heights. Their purpose is to correct intersomatic space height between vertebrae in the lumbar region of the spine.

Placement of the fusion cases has the purposes of maintaining foraminal and disc heights, maintaining lumbar spine lordosis, and to help with bone graft containment and securement until arthrodesis is achieved. In all cases, usage of the ELITE TLIF System must be accompanied by sufficient quantities of bone graft to facilitate osseointegration.

INDICATIONS

– Degenerative disc disease

– Degenerative discopathies that may cause instability

– Post-surgical discopathies

– Segmental instability

– Foraminal radicular compressions

– Degenerative Spondylolisthesis

– Low-degree Isthmic Spondylolisthesis

– Pseudarthrosis or failed arthrodesis

ESTUDIOS:

Test Methods for Intervertebral Body Fusion Devices- ASTM 2077-11/

Bacterial Endotoxin Test-ANSI/AAMIST72:2011, UPS 161, UPS 85, EP 2.6.14, and JP 4.01

Biocompatibility Test ISO 10993

CERTIFICATES

– INVIMA Sanitary Registration N°2014DM-0011623

– ISO 9001 and ISO 13485 Certifications

PRESENTATION AND PACKAGING

Implants from the ELITE TLIF System are provided unsterilized, individually packaged, and individually laser-marked. Each laser marking shows: product code, lot number, MEDIIMPLANTES logo, material symbol, 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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BUCARAMANGA, SANTANDER COLOMBIA
Industrial Park Manzana C, Cellar 10
PBX: 57 (7) 6761915 FAX: 57 (7) 6769137.

BOGOTÁ, COLOMBIA
Carrera 67 No. 167- 61. Colina Office Park
Phones: 57 (1) 6714266 - 6718655- 6680827.

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BOGOTÁ, COLOMBIA
Carrera 67 No 167-61 Colina Office Park
Phones: 57 (1) 6714266 – (1) 6718655 – (1) 6680827

BUCARAMANGA, COLOMBIA
Industrial Park Manzana C, Bodega 10
PBX 57 (7) 6861915 FAX: 57 (7) 67691377

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