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Sep 20, 2023
Businesswire
FDA Grants Second Breakthrough Device Designation for Carlsmed Technology

Carlsmed announced today that the FDA granted Breakthrough Device designation for its aprevo® technology for treatment of patients with cervical spine disease. This is Carlsmed’s second Breakthrough Device designation, complementing the company’s family of lumbar patient-specific interbody fusion devices for anterior, lateral, and transforaminal approaches.

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