Carlsmed was granted FDA 510(k) clearance to market the aprevo Cervical ACDF Interbody System. U.S. commercial launch will occur next year.
FDA previously granted Breakthrough Device designation for aprevo technology for the treatment of patients with cervical spine disease. The company’s portfolio of aprevo interbody fusion devices for the treatment of lumbar spine disease is commercially available in the U.S.
The aprevo devices are designed using Carlsmed’s proprietary technology platform that leverages AI-driven surgical planning software and digital production to create personalized spine fusion devices that can be delivered in under two weeks.
“This 510(k) clearance is a major step forward in our mission to make personalized spine surgery the standard of care,” said Mike Cordonnier, Chairman and CEO of Carlsmed. “More than 350,000 cervical fusion surgeries are performed annually in the U.S. The aprevo Cervical ACDF Interbody System will set a new benchmark for improving outcomes for these patients.”
Carlsmed was granted FDA 510(k) clearance to market the aprevo Cervical ACDF Interbody System. U.S. commercial launch will occur next year.
FDA previously granted Breakthrough Device designation for aprevo technology for the treatment of patients with cervical spine disease. The company’s portfolio of aprevo interbody fusion devices for...
Carlsmed was granted FDA 510(k) clearance to market the aprevo Cervical ACDF Interbody System. U.S. commercial launch will occur next year.
FDA previously granted Breakthrough Device designation for aprevo technology for the treatment of patients with cervical spine disease. The company’s portfolio of aprevo interbody fusion devices for the treatment of lumbar spine disease is commercially available in the U.S.
The aprevo devices are designed using Carlsmed’s proprietary technology platform that leverages AI-driven surgical planning software and digital production to create personalized spine fusion devices that can be delivered in under two weeks.
“This 510(k) clearance is a major step forward in our mission to make personalized spine surgery the standard of care,” said Mike Cordonnier, Chairman and CEO of Carlsmed. “More than 350,000 cervical fusion surgeries are performed annually in the U.S. The aprevo Cervical ACDF Interbody System will set a new benchmark for improving outcomes for these patients.”
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