Tyber Medical, a privately held medical device company focused on developing innovative orthopaedic and spine devices for private label opportunities, announces the acceptance of its entire interbody family of products into the Australian Registry of Therapeutic Goods.
Since the inception of Tyber Medical, requests for their products in Australia has been very strong. The commitment to a new market and length of the approval process discourages some, but in Australia, unlike many other markets,
TGA approval, along with product reimbursement codes, ensures straightforward access. Tyber Medical’s private label partners plan to begin launching products for this market in Q3 of 2016.
"We are very excited to be in a position to meet the strong demand for our innovative products and provide access to our unique private label model in Australia. We expect that access to the Australian market will increase our growth trajectory and allow our private label partners a rapid pathway into the Australian market and vice versa for our Australian partners desiring entry into the US and European markets," said Tyber Medical CEO, Jeff Tyber.
Tyber Medical’s market analysis shows a large and increasing opportunity for their private label model and has strategic plans for the Australian market. In the near future, look for Tyber to seek registration for its extremity line of products.
Tyber Medical, Morristown, New Jersey, a private label original equipment manufacturer (OEM), is creating new pathways to regulatory approved implants and instruments for orthopaedic companies, distributors, and hospital organizations.
Tyber Medical designs and develops class II orthopaedic systems; verifies and validates those systems using a QSR and ISO 13485 certified quality system; and pursues and maintains both US (FDA 510(k)) and OUS (CE Mark) regulatory approvals.
The Tyber Medical Cervical Plating System is the latest addition to a product portfolio which already includes a full line of spinal interbody spacers featuring both sterile and non-sterile PEEK and TyPEEK™, a proprietary titanium plasma sprayed PEEK.