Safe Orthopaedics announced the European launch of a bone substitute for its Walnut cervical cage. The company also received FDA 510(k) clearance for the SteriSpine™CC range, which includes the Walnut cage.
Although it is not commercialized in the U.S., this technology will gain more rapid approval in certain countries such as Latin America and the Asia-Pacific region.
In 2016 Safe Orthopaedics confirmed initial successful surgeries using SteriSpineCC devices, as well as expansion into Latin America under distribution agreements covering Chile and Mexico.
Sources: Safe Orthopaedics; ORTHOWORLD Inc.