We openly share technical and regulatory documentation so you can seamlessly adopt our instruments into your system.
Readily available and suitable for use with a wide range of implant systems, you can deploy with speed and confidence.
As the manufacturer of record, Enztec takes full ownership for all of our products, letting you focus on your customers.
You can be confident your local market requirements are met with our ISO 13485 certified, MDR and CFR compliant products.
Quality & Regulatory Assurance
We don't just deliver orthopaedic instruments that your surgeons love, we also provide you with full quality and regulatory support, making your adoption and deployment anywhere around the world smooth and painless. That's why our customers, big and small, keep coming back to us.
Find out how we can help you with compliance activities for all key markets such as CE (MDR), FDA, and TGA, as well as meeting your own team's needs.