Stryker OP-1 Gains HDE Status For Failed Long-Bone Nonunion Fractures
This article was originally published in The Gray Sheet
Executive Summary
Stryker plans to begin making its OP-1 (Osteogenic Protein 1) bone morphogenetic protein implant available in the U.S. by year-end under a humanitarian device exemption received from FDA Oct. 17, becoming the first company to have a BMP product reach the U.S. market.
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