FDA Clearance for Allograft Bone with Spineology Rampart Interbody Fusion Devices

By Julie A. Vetalice

Spineology received FDA 510(k) clearance in July 2016 for use of allograft bone with Rampart™ Interbody Fusion Devices.

The clearance enables the pairing of allografts from the Musculoskeletal Transplant Foundation with the Rampart product line, and also serves as a delivery platform for Spineology's Incite™ Cortical Fiber bone graft.

Rampart devices are supported by a recently-enhanced instrumentation system, and are available sterile packed.

Sources: Spineology Inc.; FDA.gov; ORTHOWORLD Inc.

Product Labels: Bone Graft Materials/DBM, Spinal Fusion

Tags: 510(k) Clearance, Regulatory