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Tyber Medical received Medical Device Regulation (MDR) CE Mark certification from BSI for its PEEK Titanium Plasma-coated cervical cages.
The certified cervical cage, a Class III device, is designed for one or more cervical spine levels from C2 to T1. The device features a robust PEEK core with an advanced Titanium Plasma coating, demonstrating improved bone cell response to support effective spinal fusion. The MDR clearance was supported by prospective and retrospective clinical data from over 150 patients in Tyber Medical’s clinical registry, showing a fusion rate of over 98%.
“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.”
Source: Tyber Medical LLC
