www.fdanews.com/articles/188887-ossdsigns-regenerative-cranial-implant-cleared-by-fda
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OssDsign’s Regenerative Cranial Implant Cleared by FDA
October 22, 2018
The FDA cleared OssDsign’s Cranioplug, a cranial implant used during neurosurgical procedures to cover and plug holes made in the skull during surgery.
The Cranioplug, which is composed of an osteoconductive calcium phosphate ceramic and reinforced with titanium mesh, is meant to help reattach cranial bone taken out during surgery.
Its ceramic component resorbs and is eventually replaced by bone as the healing process takes its course. It can be used in patients aged 12 and older.