Orthocell (ASX:OCC) received regulatory clearance from the US Food and Drug Administration for its nerve repair product, Remplir, under the 510(k) pathway, allowing sales in the US market, according to a Friday filing with the Australian bourse.

Products delivered to the US will be manufactured at the company's Western Australia facility, the filing said.

Remplir is approved for sale in Australia, New Zealand, and Singapore, with pending approvals in Canada and Thailand in the next six months, according to the filing.

Shares were down 4% in morning trade Friday.