Tyber Medical, LLC, Morristown, New Jersey, a private labeler Original Equipment Manufacturer (OEM), is creating new pathways to regulatory approved implants and instruments for orthopedic companies, large distributors, and hospital organizations. Tyber Medical designs and develops full class II orthopedic systems; verifies and validates those systems using a QSR and ISO 13485 certified quality system; and pursues and maintains both US (FDA 510k) and OUS (CE Mark) regulatory approvals. Current products include spinal interbody spacers featuring both standard sterile and non-sterile PEEK and TyPEEK™, a proprietary titanium plasma sprayed PEEK.
