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FDA Clears Use of Allograft in LDR’s Standalone ROI-C Cervical Cage -

LDR received FDA 510(k) clearance for use of allograft with the ROI-C® Cervical Cage with supplemental fixation, expanding from its previous clearance for use with autogenous bone graft.

Published clinical outcomes have demonstrated that the use of allograft in cervical interbody fusion devices to treat degenerative disc disease poses no new risks to patients.

Supplemental internal fixation is required with ROI-C; specifically, VerteBRIDGE® Plating can be inserted to “obtain fixation to the vertebral bone and create a standalone cervical interbody fusion cage construct” per the FDA filing.

Source: LDR Holding Corporation

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