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

CERTIFICATES:

– 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.