FDA Approval of subcontractor for Axor II [TM]
Integrum is glad to announce the approval of our prosthetic subcontractor by the FDA. The approval process was completed after a successful FDA inspection. This inspection included the PMA assessment in the scope. This approval secures scalable deliveries to both the US and other markets and is an important milestone in the PMA application process. The OPRA™ Axor™ II attaches to the Abutment end that is outside of the skin and acts as a safety connection between the Abutment and the prosthesis. It is designed to prevent damage to the bone-anchored Fixture and the skeleton. If overload