Bone graft device to seek PMA (premarket approval):
This article was originally published in Clinica
US orthopaedics company Stryker plans to submit a premarket approval application to the FDA this autumn for a bone graft device which contains the growth factor therapy OP-1. The device will be used in healing non-union fractures of the tibia without the need for bone grafts from the hip. Stryker's partner Creative Biomolecules, which will manufacture OP-1, is revalidating its manufacturing processes and expects to submit this with the PMA application.
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