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CE Mark AwardedUS Spine is pleased to announce it has received the CE Mark for the Preference™ Spine System throughout the European Union (EU). The CE Mark (an acronym for the French "Conformite Europeene") certifies that a product has met EU health, safety, and environmental requirements, which ensure consumer and workplace safety. The formal extension of the CE Mark's approval by GMED is based upon a complete and rigorous scientific review of the Preference™ Spine System and accessories from both a design/manufacturing/quality perspective, as well as, a comprehensive review of the commercially implanted patient experience. From a marketing perspective, the CE Mark is the European equivalent to FDA approval. All manufacturers in the European Union (EU) and abroad must meet CE Mark requirements where applicable in order to market their products in Europe and other countries around the world. Obtaining the CE Mark is a yet another major milestone in our efforts to expand the reach of our innovative technology. US Spine has entered into an agreement with the AMS Group, to distribute US Spine products in Italy and Spain. The CE Mark will allow for further expansion of the international distribution network. We are pleased to be able to offer orthopedic surgeons throughout Europe the opportunity to provide superior care to their patients through the use of our high quality, cost effective spinal products. |
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