Osteotech has announced that the FDA has cleared its 510(k) submission for the Plexur P Biocomposite for use in spinal applications as bone void filler and as a bone graft extender.
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To date, the Plexur P Biocomposite has been used by a variety of surgeons in tibial plateau fractures, tibial osteotomies and a variety of foot and ankle procedures, and can now be used in the spine. Plexur P is available as granules, cylinders, blocks, wedges and sheets.
Sam Owusu-Akyaw, Osteotech’s president and CEO, said: “We continue to receive many favorable comments from orthopedic surgeons about the efficacy of Plexur P and we will immediately offer our Plexur P product to spine surgeons supported by the clinical information and experience we have gained over the last year.”
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