K2M receives FDA clearance for new product, announces two others
K2M Group Holdings announced recent product highlights, which include U.S. Food and Drug Administration 510(k) clearance to market its Caspian Occipital Anchor Spinal System.
The company also announced the introduction of its Serengeti Minimally Invasive Retractor System in Japan and the launch of the Cayman Minimally Invasive Plate System in the United States, Australia and the United Kingdom, according to a company press release.
The Caspian Occipital Anchor allows for fixation behind the occiput, anchoring posterior cervical and thoracic constructs to the spine. The Serengeti retractor system is an existing product now available in Japan, which features a flexible polymer retractor that provides direct visualization and access to the screw heads to allow for simplified rod insertion.
The Cayman Minimally Invasive Plate System received 510(k) FDA clearance and is now available in the United States, Australia and the United Kingdom, according to the press release. The product’s single-level, stackable design allows for single- and multi-level constructs.
Reference: www.k2m.com