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News Breaks
October 25, 2012
08:08 EDTRTIXRTI Biologics says working with FDA to address concerns
On Oct. 23, 2012 the company received a warning letter from the FDA related to environmental monitoring activities in certain areas of its Alachua, Fla. processing facility. The company is committed to actively working with the FDA to address their concerns. The warning letter does not restrict the company’s ability to process or distribute implants, nor does it require the withdrawal of any implants from the marketplace. The issuance of the warning letter has no impact on patient safety.
News For RTIX From The Last 14 Days
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February 11, 2016
16:30 EDTRTIXRTI Surgical announces agreement with Oxford Performance Materials
RTI Surgical announced a new agreement with Oxford Performance Materials, or OPM, a pioneer in advanced materials and additive manufacturing for biomedical applications. The agreement, effective Feb. 4, 2016, grants RTI an exclusive license to OPM's OsteoFab technology platform for spinal applications in all U.S. markets. OsteoFab is a next-generation implant manufacturing process that builds implantable medical devices, layer-by-layer, using only laser light and OPM's OXPEKK polymer. The OsteoFab process and OXPEKK material combine to create implants that are designed to enable bone ongrowth. OXPEKK is a proprietary high-performance biocompatible polymer formulation from OPM, designed for medical applications. This strong, pure, radiolucent, hydrophilic, load-bearing material boasts a successful history in orthopedic implant applications. Under the agreement, OPM will manufacture RTI's spinal implant designs using OsteoFab technology, and RTI will oversee finishing steps, packaging, marketing and distribution of finished products.

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