Certification Marks Key Milestone in Expanding Global Market Access for Tyber Medical’s Comprehensive Product Portfolio
BETHLEHEM, Pa., Dec. 5, 2024 /PRNewswire/ — Tyber Medical LLC, a leading provider of private-label orthopedic and spinal implants, proudly announces that it has received Medical Device Regulation (MDR) CE Mark certification from BSI for its PEEK Titanium Plasma-coated cervical cages. This certification for Tyber Medical’s innovative technology is a pivotal step toward bringing the company’s extensive product portfolio to the global market, aligning with stringent European Union regulatory standards for quality, safety, and performance.
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. MDR certification endorses the technology and safety profile of Tyber Medical’s PEEK Titanium Plasma-coated cervical cages. The MDR clearance was supported by prospective and retrospective clinical data from over 150 patients in Tyber Medical’s extensive clinical registry, showing a fusion rate of over 98%. 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.”
About Tyber Medical LLC
Tyber Medical LLC is a leading orthopedic device manufacturer providing rapid access to FDA-cleared and CE-marked, private-label, portfolio-enhancing, regulatory-approved orthopedic implants for the spinal, extremity, and trauma markets. Since its founding in 2012, the company has released over 50 spine, extremity, and trauma systems. Tyber Medical aims to develop and utilize differentiated bioengineered technologies, including advanced surface treatments and coatings, to create cutting-edge orthopedic implants.
Contact:
Eric Dickson
Tyber Medical
Phone: 610-849-1710
Email: [email protected]
SOURCE Tyber Medical