K2M received 510(k) clearance from the U.S. Food and Drug Administration to market MESA Hooks — the latest implant addition to the MESA Deformity Spinal System — and also received CE Mark approval.
The MESA Hook extension to the existing MESA Deformity Spinal System provides a low-profile option to this system. The MESA Deformity System, designed for use in complex spine surgeries.
"We are pleased to receive 510(k) clearance and the CE Mark for MESA Hooks, which will enhance our portfolio and support our effort to expand our global penetration of the complex spine market with the MESA Spinal Deformity System. The unique low-profile MESA Hooks in combination with differentiated technology such as the MESA Rail provide surgeons with a wide range of fixation option for patients with severe spinal deformities," said Eric Major, president and CEO of K2M.
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