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.