Carlsbad-based Alphatec Holdings Inc. has received clearance from the U.S. Food and Drug Administration to market and sell its spinal disorder corrective device.
The company filed for FDA compliance in the fourth quarter of 2012, it said, in a statement.
The patented Alphatec Solus ALIF device is a titanium ring that help’s stabilize a patient’s spinal column. It’s surgically fitted through a minimally invasive procedure, the company said.
The product has been on the market in Europe since January, and the company said that sales there have been successful.
An estimate from market research firm Millennium Research Group said the potential 2013 sales of these kinds of devices are about $129 million.
— SDBJ Staff Report