K2M, Inc.

Fulfilling or delegating all of the following responsibilities for the Allendale and Leesburg campuses, including ensuring: - The conformity of the devices is appropriately checked, in accordance with the quality management system under which the devices are manufactured, before a device is released; - The post-market surveillance obligations are compiled in accordance with Article 10 (10); - The reporting obligations referred to in Articles 87 to 91 are fulfilled.

Fulfilling or delegating all of the following responsibilities for the Allendale and Leesburg campuses, including ensuring: - the technical documentation and the EU DOC are drawn up and kept up-to-date; - In the case of investigational devices, the statement referred to in Section 4.1 of Chapter II of Annex XV is issued.