Tyber Medical Secures CE Mark Certification for Innovative Cervical Cages to Enhance Global Market Presence
Tyber Medical LLC, known for its advancements in orthopedic device manufacturing, has recently accomplished a significant milestone by obtaining the Medical Device Regulation (MDR) CE Mark certification from BSI for its state-of-the-art PEEK Titanium Plasma-coated cervical cages. This certification marks a pivotal step for the company, allowing it to broaden its reach in the global medical market while adhering to the strict quality and safety standards mandated by the European Union.
The certified cervical cage is classified as a Class III device and is specifically engineered to be used across various cervical spine levels ranging from C2 to T1. Its design incorporates a robust PEEK core, enhanced by a novel Titanium Plasma coating. This innovative layering significantly improves the response of bone cells, promoting more effective spinal fusion. By achieving MDR certification, Tyber Medical has validated the safety and efficacy of its cervical cages, which are backed by comprehensive clinical data that encompasses both prospective and retrospective studies involving over 150 patients. Notably, the clinical registry showcases an impressive fusion rate exceeding 98%, underscoring the company’s commitment to delivering optimal patient outcomes through reliable spinal solutions.
Jeff Tyber, the CEO and President of Tyber Medical, expressed his enthusiasm about this achievement, stating, "Securing MDR certification for our PEEK Titanium Plasma-coated cervical cages represents a significant achievement for 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."
Tyber Medical LLC, established in 2012, has positioned itself as a leader in the orthopedic device sector by providing rapid access to both FDA-cleared and CE-marked orthopedic implants. With a robust portfolio that includes over 50 spine, extremity, and trauma systems, the company continuously seeks to innovate by implementing advanced surface treatments and coatings. Tyber Medical’s strategic focus includes the development of unique bioengineered technologies, which are integral to the creation of cutting-edge orthopedic implants.
The success of the PEEK Titanium Plasma-coated cervical cage is not just a win for Tyber Medical; it also marks an advancement in orthopedic solutions available to medical professionals and patients around the world. As the demand for high-quality spinal implants continues to rise, the certification allows Tyber Medical to continue enhancing its offerings in the market, ultimately contributing to improved surgical outcomes and patient safety.
This significant milestone is expected to pave the way for Tyber Medical’s sustained growth in the international arena, as it aligns with the company’s vision of improving accessibility to innovative orthopedic solutions. By continually meeting and surpassing regulatory requirements, Tyber Medical demonstrates its dedication to quality and safety in the healthcare industry. With a focus on patient-centered outcomes, the company is poised to make a lasting impact in the field of orthopedic devices, ensuring that healthcare providers and patients alike have access to the best possible spinal solutions.
The certified cervical cage is classified as a Class III device and is specifically engineered to be used across various cervical spine levels ranging from C2 to T1. Its design incorporates a robust PEEK core, enhanced by a novel Titanium Plasma coating. This innovative layering significantly improves the response of bone cells, promoting more effective spinal fusion. By achieving MDR certification, Tyber Medical has validated the safety and efficacy of its cervical cages, which are backed by comprehensive clinical data that encompasses both prospective and retrospective studies involving over 150 patients. Notably, the clinical registry showcases an impressive fusion rate exceeding 98%, underscoring the company’s commitment to delivering optimal patient outcomes through reliable spinal solutions.
Jeff Tyber, the CEO and President of Tyber Medical, expressed his enthusiasm about this achievement, stating, "Securing MDR certification for our PEEK Titanium Plasma-coated cervical cages represents a significant achievement for 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."
Tyber Medical LLC, established in 2012, has positioned itself as a leader in the orthopedic device sector by providing rapid access to both FDA-cleared and CE-marked orthopedic implants. With a robust portfolio that includes over 50 spine, extremity, and trauma systems, the company continuously seeks to innovate by implementing advanced surface treatments and coatings. Tyber Medical’s strategic focus includes the development of unique bioengineered technologies, which are integral to the creation of cutting-edge orthopedic implants.
The success of the PEEK Titanium Plasma-coated cervical cage is not just a win for Tyber Medical; it also marks an advancement in orthopedic solutions available to medical professionals and patients around the world. As the demand for high-quality spinal implants continues to rise, the certification allows Tyber Medical to continue enhancing its offerings in the market, ultimately contributing to improved surgical outcomes and patient safety.
This significant milestone is expected to pave the way for Tyber Medical’s sustained growth in the international arena, as it aligns with the company’s vision of improving accessibility to innovative orthopedic solutions. By continually meeting and surpassing regulatory requirements, Tyber Medical demonstrates its dedication to quality and safety in the healthcare industry. With a focus on patient-centered outcomes, the company is poised to make a lasting impact in the field of orthopedic devices, ensuring that healthcare providers and patients alike have access to the best possible spinal solutions.
Topics Health）
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