ACIFBOX Plate-Cage
This device is an anterior intersomatic cervical cage combined with a cervical plate. It is intended to reduce the pathologies of the cervical spine by restoring the disc height as well as the physiological bending of the spine and by allowing the fusion of vertebral bodies between them.
Acifbox implants are used with dedicated instruments for site preparation, implant insertion and removal.
Acifbox implants are for single use only.
Implant material :
- Cage : PEEK-OPTIMA® (ASTM F2026) + Gold (ASTM B562) + Titanium (EN ISO 5832-3 ASTM F136)
- Plate : Titanium (EN ISO 5832-3 ASTM F136)
- Screws : Titanium (EN ISO 5832-3 ASTM F136)
Instrument material : Stainless steel, silicone and TA6V
This medical device is used (and only) to treat cervical disc diseases defined as refractory radiculopathy (irradiant pain) and/or myelopathy (weakness) with herniated disc and/or formation of osteophyte and/or spinal cord compression.
It has a graft chamber intended to be filled with bone substitute, wide enough to achieve a good bone graft.
ACIFBOX implants can be used in skeletally mature individuals (adults) and in adolescent.
ACIFBOX cages can be used in skeletally mature individuals.
This medical device is used (and only) to treat cervical disc diseases defined as refractory radiculopathy (irradiant pain) and/or myelopathy (weakness) with herniated disc and/or formation of osteophyte and/or spinal cord compression. The ACIFBOX cervical anterior spinal cages are anatomically designed. They make it possible to restore disc height and physiological lordosis. It has graft window intended to be filled with bone substitute, wide enough to achieve a good bone graft.
Please read the informations in the instructions for use carefully.
ACIFBOX implants are class IIb healthcare products marked CE2803 under the relevant European regulations.
For proper implantation, ACIFBOX must be used with a specific set of instruments and reusable Class I surgical instruments marked CE/CE0197 under the appropriate European regulations. The use of these instruments is described in the surgical technique.
June 2024
Manufacturer: DISTIMP SAS 7, allée du Moulin Berger 69130 Ecully, France
OPEN CERVICAL ARTHRODESIS
Link to: ACIFBOX cervical Cage with Blade
ACIFBOX cervical Cage with Blade
Anterior cervical interbody fusion cage
Link to: ACIFBOX Stand alone cervical Cage
ACIFBOX Stand alone cervical Cage
Anterior cervical interbody fusion cage
