Manufacturer
Ecential RoboticsOp.n(TM) Navigation
Country / Region:France (FR)Submission type:Traditional
Product code OLO· 21 CFR 882.4560
Product code
OLO
21 CFR 882.4560
Predicate devices
0
Cited in this 510(k)
Cited as predicate
0
Device details
FDA 510(k) registration fields
- K number
- K242914
- Device name
- Op.n(TM) Navigation
- Company
- Ecential Robotics
- Country / Region
- France(FR)
- Product code
- OLO
- Device class
- Class 2
- Regulation number
- 21 CFR 882.4560
- Date received
- 2024-09-24
- Decision date
- 2025-03-07
- Submission type
- Traditional
- Technology type
- Software Navigation(AI inferred)
- Clinical applications
- Spine SurgeryNavigation System
- Primary application
- Spine Surgery
- Classification source
- AI classified
Indications for Use
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.
Intended Use
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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