CE Mark Enables Medical Device Company to Sell in Europe
LEESBURG, Va.—-K2M, Inc., the spinal device company developing innovative and simplified solutions for the treatment of complex spinal pathologies and procedures, today announced that it has entered the international spine market via its recently acquired ISO 13485 certification and CE Mark clearance for its spinal devices. Similar to 510(k) approval in the United States, the CE Mark allows for sale and distribution of products for specific indications within Europe and other countries. K2M’s international expansion has begun with the successful introduction of its products in Spain and the United Kingdom. The K2M product portfolio cleared for sale encompasses a full array of products developed to treat complex spinal conditions and includes the RANGE™ Spinal System, MESA™ Spinal System, DENALI™ Spinal System, PYRENEES™ Cervical Plate System and ALEUTIAN™ Spacer Systems.
“ISO certification and CE clearance for our products are important milestones in our international efforts and will be key to fueling our continued growth at K2M,” stated Eric Major, K2M’s President and CEO. “We are committed to expanding the availability of our innovative technology to countries around the world and supporting surgeons treating the most difficult spinal deformities. Our mission is to be the worldwide leader in providing solutions to complex spinal pathologies.”