Certification
TiTaMED Spinal System
FDA Approval
Our covering letter from FDA for our 510(k). (3 pages)
Quality Management System - Medical Manufacturing
ISO 13485
Our ISO 13485 certificate issued by Lloyds Register for medical devices and implant manufacturing. (1 certificate)
ISO 13485 Certificate
Quality Management System - Aerospace Manufacturing
AS9100
Our Aerospace accreditation (AS9100 Rev C) issued by Novo Star. (1 certificate)
For manufacture only, not design.
BEE
BEE Level 4
TiTaMED is BEE level 4. (1 certificate)