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www.fdanews.com/articles/109010-osteotech-8217-s-biocomposite-receives-fda-clearance

Osteotech’s Biocomposite Receives FDA Clearance

July 30, 2008

The FDA has granted 510(k) clearance to Osteteotech for its Plexur M biocomposite for use in spinal applications.

The product may be used with autograft as a bone void filler in the spine. It is the second bone-polymer biocomposite developed under the company’s Plexur technology, Osteotech said.

In March, the company received FDA clearance to use the product in filling bony gaps in the pelvis and extremities.