Globus Medical is not a "notified body"; a notified body is an independent, legally designated organization accredited by national regulatory authorities to conduct conformity assessments and certify medical devices for CE marking compliance in regions like the European Union. Instead, Globus Medical is a commercial medical device manufacturer and designer that creates, tests, and markets musculoskeletal products, meaning it must submit its medical devices to official third-party notified bodies and regulatory agencies like the FDA to secure required commercial clearances and approvals.