Tyber Medical, LLC, is medical device company structured around titanium plasma spray coated interbody fusion devices. The firm is a private labeler Original Equipment Manufacturer (OEM) designing full class II orthopedic systems, verifying and validatingthose systems using a QSR and ISO 13485 certified quality system The firm pursues and maintains both US (FDA 510k) and OUS (CE Mark) regulatory approvals. Products have included spinal interbody spacers featuring both standard sterile and non-sterile PEEK and TyPEEKâ¢, a proprietary titanium plasma sprayed PEEK. Serves orthopedic companies, stocking distributors, and hospitals and GPOs, addressing the industryâs need for rapid access to FDA cleared and CE Marked implants in the spine and extremity/trauma markets and focused on rapid commercialization and bioengineered technology platforms having released 14 spine and 25 trauma/extremity systems since its founding in 20
