Certified Quality Management

Orthopaedic instruments must meet high quality demands for safety and performance. Quality is inherent in everything we do at Enztec. We are driven to provide innovative products and services that meet regulatory requirements through our effective quality systems.

Enztec has an ISO 13485 certified quality management system and has achieved MDR certification for our Class Ir, Im, and IIa orthopaedic instrumentation.

ISO 13485 Certificate


MDR Certificate


Instructions for Use

Instructions for use are available to download. To request physical copies of the IFU, please contact us, and a printed copy of the most recent revision will be provided to you at no cost.

Take me to the IFUs

Additional Product Information

Some of our products may have additional instructions regarding best practices for use, (dis)assembly, or cleaning. These can be found on the specific product page as a downloadable item.

    Hip Instruments    

  Knee Instruments   

General Instruments