www.fdanews.com/articles/192876-omnia-medical-gets-510k-clearance-for-cervical-vbr-system
Omnia Medical Gets 510(k) Clearance for Cervical VBR System
September 26, 2019
The FDA granted 510(k) clearance to Omnia Medical’s Boxcar, a cervical vertebral body replacement (VBR) system used in cervical-corpectomy procedures.
The single-use system is used to replace damaged, collapsed or unstable vertebral body in the neck region and comes in two footprints.
Spinal height and lordosis is easily adjustable using spacers and endplates, and the system features a hollow center and holes to accommodate an autograft or allograft, the company said.