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K2M receives 510(k) clearance, CE mark for MESA Hooks

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K2M Group Holdings announced it has received 510(k) clearance from the U.S. Food and Drug Administration to market MESA Hooks for use in complex spine procedures.

The company also announced it has received CE mark for the product, which will allow it to expand the product globally, according to a press release.

The MESA Hook extension to the existing MESA Deformity Spinal System is designed for use in complex spine surgeries. It contains a wide range of implants and instruments for the treatment of deformity, trauma and tumor.

K2M’s low-profile, top-loading MESA technology features zero-torque technology, which offers surgeons the ability to one-step lock without torsional stress applied to the spine, according to the release. The MESA Hooks line extension includes a variety of transverse process hooks, laminar hooks and pedicle hooks.

Reference: www.k2m.com