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Sources: EU EUDAMED, US FDA
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Country: Germany
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DTB Gesellschaft für digitale Therapiebegleitung mbH
Manufacturer
🇩🇪 Germany
DTS-DESIGN GmbH
Importer
🇩🇪 Germany
BrainLAB's VectorVision spine is intended for use as an intraoperative image-guided localization system for minimally invasive surgery. It links a freehand probe, tracked by a passive marker sensor system to virtual computer image space on a patient's preoperative image data that is processed by a VectorVision workstation. The system is indicated for any medical condition in which the use of stereoscopic surgery may be appropriate and where a reference to a rigid anatomical structure, such as the skull, the pelvis, a long bone or vertebra can be identified relative to a CT, x-ray, or MR-based model of the anatomy.
FDA Enforcement
Class II
·Terminated·Brainlab AG·February 19, 2014
Orthana GmbH
Importer
🇩🇪 Germany·12 Manufacturers
SPIGGLE &THEIS Medizintechnik GmbH
Importer
🇩🇪 Germany·19 Manufacturers
Ortho Organizers GmbH
Importer
🇩🇪 Germany·34 Manufacturers
Shanghai International Holding Corp. GmbH(Europe)
Authorized representative
🇩🇪 Germany·637 Manufacturers·33064 Devices