Interspinous fixation system
FIXPINO, an Interspinous Implant, is an s-shaped metallic device that is inserted between the spinous processes. It is made of a single machined piece of Ti-6Al-4V Eli titanium alloys (ASTM F 136). The FIXPINO is designed to increase the cross-sectional diameter of the stenotic canal in patients suffering from neurogenic claudication. The S-shaped spacer fits between the spinous processes and the wings are designed to prevent the implant from moving. Furthermore, the S-shaped spacer can make inserting the implant easy because the S-shape can be compressed. DioMedical Co., Ltd. utilize the state of the art technology and apply the essential requirements of cGMP and ISO 14630 from the beginning stage of the device design to manufacturing and inspection.
- Class IIb according to the Rule 8 of Classification Criteria, Annex IX, MDD 93/42/EEC.
- Class II according to the QSR:21 CFR.820./col.
- Common name: interspinous fixation system.
- Proprietary name: Fixpino.
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