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Product / Company Performance

Cerapedics Launching IDE Study of P-15L Bone Graft in TLIF -

Cerapedics received FDA approval for an Investigational Device Exemption clinical trial of P-15L Peptide Enhanced Bone Graft vs. autograft in transforaminal lumbar interbody fusion to treat degenerative disc disease. The prospective, single-blinded, multi-center, randomized, non-inferiority pivotal study will enroll 364 patients at up to 30 U.S. sites, with follow-up at 6 weeks, 3 months, 12 months and 24 months. Investigators can use any FDA-cleared static PEEK interbody and any FDA-cleared pedicle fixation system delivered in an open or minimally invasive technique. (Cerapedics, 3/14/18)