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K2M’s MESA® Mini and DENALI® Mini Spinal Systems Receive Additional FDA Clearance for Posterior Cervical Spine Fixation
Apr. 06, 2016 10:51AM PST
Medical Device Investing
K2M Group Holdings, Inc. (NASDAQ:KTWO), a global medical device company focused on designing, developing and commercializing innovative and proprietary complex spine and minimally invasive spine technologies and techniques, today announced it has received 510(k) clearance from the U.S. Food and Drug Administration (FDA) for expanded indications of its MESA® Mini Spinal System and DENALI® Mini …
K2M Group Holdings, Inc. (NASDAQ:KTWO), a global medical device company focused on designing, developing and commercializing innovative and proprietary complex spine and minimally invasive spine technologies and techniques, today announced it has received 510(k) clearance from the U.S. Food and Drug Administration (FDA) for expanded indications of its MESA® Mini Spinal System and DENALI® Mini Spinal System.
According to the news:
The MESA Mini and DENALI Mini Spinal Systems function as adjuncts to fusion, providing stabilization of the posterior cervical and thoracic spine. Both systems were previously cleared for use in the posterior thoracic spine, from T1-T3. The new clearance now allows for the systems to be used in the posterior cervical spine, from C1-C7, in addition to the thoracic spine.
Eric Major, K2M’s President and CEO commented:
With this FDA clearance, we are excited to provide surgeons treating the cervico-thoracic regions of the spine with expanded use of our MESA Mini and DENALI Mini Spinal System. This new clearance reinforces the clinical effectiveness of posterior cervical screws, differentiates K2M from our competitors in the complex spine cervical markets that currently lack this important regulatory indication, and clears the path for our future development of innovative technologies to treat spinal conditions in the posterior cervical spine.