RTI Surgical Receives Additional 510(k) Clearance for Streamline OCT System

By Julie A. Vetalice

RTI Surgical received an expanded FDA 510(k) clearance for the Streamline OCT Occipito-Cervico-Thoracic System, including an indication for polyaxial screw placement in cervical spine, and also clearance for a dual diameter transition rod.

While the new indications span from the Occiput to T3, additional levels of fixation can be accomplished by connecting to other RTI pedicle screw systems through the newly-cleared transition rod or available rod-to-rod connectors.

Pioneer Surgical launched the Streamline portfolio in 2011. RTI acquired Pioneer two years later. Various extensions to the line have included Streamline MIS and Streamline OCT.

Sources: RTI Surgical, Inc.; ORTHOWORLD Inc.

Product Labels: Spinal Fusion

Tags: 510(k) Clearance, Regulatory