Product Certifications and Clearance
Quality Management System-ISO 13485:2003 (PDF)
Our organization has demonstrated its ability to provide medical devices that consistently meet customer and regulatory requirements. We have accomplished this by recognizing quality as the most important ingredient when manufacturing our product. K2M products have demonstrated their safety and effectiveness both in domestic (pre-market notification, 510(k)) approval via the FDA (Food and Drug Administration) and overseas (CE Mark).www.fda.gov
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