Product code OLO· 21 CFR 882.4560
Product code
Predicate devices
Cited as predicate
FDA 510(k) registration fields
Op.n™ Navigation is indicated for the positioning of compatible surgical instruments to be used by surgeons during general spinal surgery. The guidance is based on an intra-operative surgical plan developed with Op.n™ Navigation Software and based on intra-operative 3D images provided by a compatible imaging system. The device is indicated for the placement of pedicle screws, in instrument navigation mode, in vertebrae with a posterior approach in the thoracolumbar region. Op.n™ Navigation Software is indicated for the navigation of compatible surgical instruments to be used by surgeons.
Op.n™ Navigation is indicated for the positioning of compatible surgical instruments to be used by surgeons during general spinal surgery. The guidance is based on an intra-operative surgical plan developed with Op.n™ Navigation Software and based on intra-operative 3D images provided by a compatible imaging system. The device is indicated for the placement of pedicle screws, in instrument navigation mode, in vertebrae with a posterior approach in the thoracolumbar region. Op.n™ Navigation Software is indicated for the navigation of compatible surgical instruments to be used by surgeons.
Summary parsed at:2026-06-19 05:18:12 UTC
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