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FDA accepts OP-1 implant filing:

This article was originally published in Clinica

Executive Summary

Stryker's premarket approval (PMA) application for its orthopaedic tissue engineering product OP-1 Implant has been accepted by the US FDA. The implant combines the bone growth factor OP-1 with type 1 bone collagen as an alternative to painful bone autografts for non-union fractures. Stryker filed the PMA last month following a series of delays caused by regulatory changes and the integration of manufacturing facilities for OP-1 (see Clinica No 862, p 19).





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