Implanet’s Swingo anterior cervical cage earned the FDA’s 510(k) clearance, according to a March 3 news release.
The Swingo cage range includes multiple implant sizes and is made with 3D printing technology. It can be used for all types of spine procedures.
“In the short term, combined with JSS (posterior fusion system), it will enable us to offer a comprehensive range of implants dedicated to spinal fusion in the United States, our priority market,” Ludovic Lastennet, CEO of Implanet, said in the release. “The potential synergies created by our expanded product portfolio fully support our strategy to strengthen our presence in the U.S. This represents another structural step in our development plan, aimed at reinforcing our offering in the spine surgery segment within a market estimated at $1.35 billion. This clearance will also allow us to commercialize this range, in addition to our existing portfolio, with many our distributors in countries recognizing U.S. FDA regulations, pending CE marking for the European market.”
