K2M MESA Mini and DENALI Mini Spinal Systems Receive Additional FDA Clearance in Posterior Cervical Spine

By Julie A. Vetalice

K2M received FDA 510(k) clearance for expanded indications of its MESA® Mini and DENALI® Mini spinal systems for stabilization of the posterior cervical and thoracic spine as an adjunct to fusion.

Both systems were previously cleared for use in the posterior thoracic spine (T1-T3). The new clearance allows for use in the posterior cervical spine (C1-C7), as well.

Source: K2M, Inc.

Product Labels: Cervical Spine, Spinal Fusion

Tags: 510(k) Clearance, Regulatory