FDA clears 2 K2M spine systems — 4 notes

The FDA issued 510 (k) clearances for K2M’s MESA Mini Spinal System and DENALI Mini Spinal System, according to EconoTimes Business.

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Here are four notes:

 

1. The two spinal systems work to stabilize the posterior cervical and thoracic spine.

 

2. Previously, the FDA cleared both systems for posterior thoracic spine use from T1 to T3.

 

3. The most recent clearance allows surgeons to use the systems in the posterior cervical spine from C1 to C7, as well as the thoracic spine.

 

4. The MESA Mini and the DENALI Mini Spinal Systems consist of 3.55 mm diameter rod systems, featuring various hook and rod options.

 

“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 Systems,” said Eric Major, K2M’s President and CEO.

 

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