Interbody Fusion

Cervical plate ACIFBOX

Anterior cervical plate

This device is an anterior cervical plate.
This anterior cervical plate must be used as supplemental stabilization to an ACIFBOX cervical cage ACB.
It is  intended to stabilise the spinal segment during the fusion process and to secure the cage in the intervertebral space.

ACIFBOX implants  are used with dedicated instruments for site preparation, implant insertion and removal.

ACIFBOX implants are for single use only.

Informations

This device is an anterior cervical plate. It is  intended to stabilise the spinal segment during the fusion process and to secure the cage in the intervertebral space.

ACIFBOX implants are used with dedicated instruments for site preparation, implant insertion and removal.

ACIFBOX implants are for single use only.

Implant material
• Plate : Titanium (EN ISO 5832-3 ASTM F136)
• Screws : Titanium (EN ISO 5832-3 ASTM F136)

Instrument material
• Stainless steel, silicone and TA6V

Indications
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.

ACIFBOX implants can be used in skeletally mature individuals (adults) and in adolescent.

Features

Plate ACBP
• Pre bent
• From 1 to 4 levels
• Low profile with 1.8mm thickness

Screws Diam. 4.0mm & Diam. 4.5mm
• Self-drilling
• Anti backout system

Product Range

Plate
• Length : 21mm to 101mm 
• Width : 17mm
• A total of 17 references

Screws
• Length from 10mm to 22mm

Regulatory Notices

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 Class I instruments and reusable surgical instruments marked CE/CE0197 under the appropriate European regulations.

The use of these instruments is described in the surgical technique.

Manufacturer
DISTIMP: 7, allée du Moulin Berger 69130 Ecully, France

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