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Medical Devices / Submissions and Approvals

Cerapedics Earns Premarket Approval for Bone Graft

Nov. 20, 2019

The FDA has granted Cerapedics premarket approval for its i-FACTOR peptide enhanced bone graft for anterior cervical discectomy and fusion (ACDF) procedures.

The drug-device combination product uses synthetic small peptide technology to speed up the formation of new bone in patients with degenerative disc disease.

The premarket approval allows the labeling to state that clinical data showed statistical superiority over autologous bone graft was maintained in its second-year follow-up.

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