Cerapedics receives PMA supplement approval for peptide bone graft in ACDF

Alan Condon -   Print  |

The FDA approved Cerapedics premarket approval supplement for i-Factor in anterior cervical discectomy and fusion procedures in patients with degenerative disc disease.

Three things to know:

1. The company requested approval for an updated package insert that includes 24-month follow-up data from subjects in the original clinical study.

2. i-Factor is a peptide enhanced bone graft that Cerapedics commercialized in 2016.

3. The biologic bone graft incorporates a small peptide as an attachment factor to stimulate the natural bone healing process.

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