Tyber Medical, a privately held medical device company focused on developing innovative spine and orthopaedic devices for private label opportunities, announces CE Mark approval for TyPEEK, a proprietary titanium plasma sprayed PEEK interbody system. TyPEEK interbody fusion devices are specifically designed for situations where PEEK alone may not provide the best setting for fusion.
TyPEEK is designed to offer the benefits of bone growth with titanium along with the modulus and the post op imaging characteristics of PEEK. The TyPEEK interbody fusion devices include configurations for Anterior Cervical (ACIF), Anterior Lumbar (ALIF), Posterior Lumbar (PLIF), Oblique Lumbar (OLIF), Transforaminal Lumbar (TLIF), and Direct Lateral (DLIF) Interbody Spacers.
"Receiving ISO 13485 certification and CE Mark approval within our first year demonstrates the ability of our quality system and our team to efficiently design, develop and gain regulatory approval for products that have leading edge technology, while ensuring that they are safe and effective," said Mark Schenk, Director of Regulatory Affairs and Quality Assurance for Tyber Medical.
"The Tyber Medical Interbody portfolio offers our customers immediate access to a regulatory approved system, ranging from economical non-sterile PEEK to our highly differentiated proprietary Titanium Plasma Sprayed TyPEEK," said Jeff Tyber, Chief Executive Officer of Tyber Medical. "We are excited to give the versatility and customization of choice back to our customer, with the option to purchase a full system solution or an al la cart selection; trays, instrument, or implant."