Safe Orthopaedics Expands Cervical Products with Europe Launch, 510(k)

By Julie A. Vetalice

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.

Product Labels: Cervical Spine

Tags: Product Launch