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Fixpino is an S-shaped metallic device for interspinous fixation

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Typical Indications

    The Fixpino, interspinous fixation system, is designed to insert the cross-sectional diameter of the stenotic canal in patients suffering from neurogenic claudication.
    The Fixpino is an S-shaped metallic device that is inserted between the spinous processes. 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 spacer can be compressed


Overview

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. The S-shaped spacer can simplify insertion of the implant because the S-shape can be compressed.
HUVEXEL utilized of cGMP and ISO 14630 from the beginning stage of the device design to manufacturing and inspection.

Device Name

1) Common name : interspinous fixation system
2) Proprietary name : Fixpino


Classification

  • 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.

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Fixpino

Indication for Use

The Fixpino, interspinous fixation system, is intended radiographically confirmed moderate to severe stenosis with neural element compromise resulting in claudication and/or radicular symptoms isolated to 1 or 2 levels, in the region of L1 to S1 with or without concomitant low back pain.


Fixpino

Part number A (mm) B (mm) C (mm)
DLS0820 36.7 20 8.1
DLS1020 38.7 20 10.1
DLS1220 40.7 20 12.1
DLS1420 42.7 20 14.1
DLS1620 44.7 20 16.1

Fixpino DBM

Part number A (mm) B (mm) C (mm)
DLS0820 36.7 20 8.1
DLS1020 38.7 20 10.1
DLS1220 40.7 20 12.1
DLS1420 42.7 20 14.1
DLS1620 44.7 20 16.1

Fixpino, interspinous fixation system, is designed to relieve patients suffering from neurogenic claudication. The Fixpino has an S-shaped design that is inserted between the spinous processes. The S-shaped spacer fits between the spinous processes the wings are designed to prevent the implant from moving. HUVEXEL’ S-shaped Fixpino design allows for inserting the implant without difficulty due to its unique design

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This product is medical device, Please see the IFU (instruction for use) before using

Advertisement Review No. 2013-I10-01-0505.

CE approved