PRODUCT NAME: TRANSPEDICULAR FIXATION SYSTEM
COMMERCIAL NAME: APOLO SYSTEM
MANUFACTURER: Mediimplantes S.A.
MANUFACTURING MATERIAL: Ti 6Al 4V ELI (Extra low interstitial) Alloy for Surgical Implant Applications – UNS R56401, ASTM F136-02.
APOLO is a system composed of intervertebral bodies with diameters of 11, 12 and 13 mm., as well as lengths of 20 and 25 mm.
APOLO has a special design that allows to save valuable time by skipping certain steps during surgical procedures. It has a threaded conical end, which allows for slight perforation. Its thread provides good strength and grip.
– Patients that show chronic or severe lower back pain caused by disk degenerative disease.
– Patients with micro-instability.
STUDIES AND TESTS:
– Standard Test Methods for Spinal Implant Constructs in a Vertebrectomy Model – ASTM F1717- 04.
– Tests Methods for Intervertebral Body Fusion Devices – ASTM F2077.
– ASTM E8 Mechanical and Metallurgical Characterization
– INVIMA SANITARY REGISTRATION 2007DM-0000663
– ISO 9001 and ISO 13485 Certificates.
PRESENTATION AND PACKAGING
Implants from the APOLO 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 arrange implant references in an organized fashion.
STORAGE AND AVAILABILITY:
Immediate availability and easily stored. Does not need refrigeration or any special handling besides maintaining cleanliness condition to guarantee sterilization results.
Send us your query or request,
we will contact you to provide advice.
BUCARAMANGA, SANTANDER COLOMBIA
Industrial Park Block C, Cellar 10
PBX: 57 (7) 6761915 FAX: 57 (7) 6769137.
Avenue 67 No. 167- 61. Colina Office Park
Phones: 57 (1) 6714266 - 6718655- 6680827.