Tyber Medical’s PEEK Titanium Plasma-Coated Cervical Cages Gain Class III MDR CE Mark

Tyber Medical, a leading provider of private-label orthopedic and spinal implants, has received the Medical Device Regulation (MDR) CE Mark certification from BSI for its PEEK Titanium Plasma-coated cervical cages. This clearance underscores the company’s commitment to advancing patient outcomes through reliable and accessible spinal solutions.

“Securing MDR certification for our PEEK Titanium Plasma-coated cervical cages represents a significant achievement for Tyber Medical,” said Jeff Tyber, CEO and President of Tyber Medical. “This milestone validates our efforts to expand our product offerings in global markets and demonstrates our commitment to meeting the highest standards in medical device technology. We are excited to bring this innovative solution to patients and healthcare providers worldwide.”

This cervical cage is designed for one or more cervical spine levels from C2 to T1. The device features a PEEK core with an advanced Titanium Plasma coating for an improved bone cell response to support effective spinal fusion. 

MDR certification endorses the technology and safety profile of Tyber Medical’s PEEK Titanium Plasma-coated cervical cages. Prospective and retrospective clinical data from over 150 patients in Tyber Medical’s extensive clinical registry supported the MDR clearance. Studies showed a fusion rate of over 98%. 

This certification is a pivotal step in bringing the company’s product portfolio to the global market, aligning with EU regulatory standards for quality, safety, and performance.