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Legal, Clinical & Regulatory

Orthofix M6-C Disc Granted FDA Premarket Approval

Clinical data on the disc demonstrated meaningful improvement in pain and lowered disability vs. anterior cervical discectomy and fusion in the treatment of cervical radiculopathy, with or without cord compression.

Orthopaedic Companies Collaborate with NESTcc on Real-World Evidence Considerations

The National Evaluation System for health Technology Coordinating Center launched its first round of Real-World Evidence Test-Cases, which include a focus on postmarket surveillance in orthopaedics. NESTcc's Deputy Director discusses what manufacturers should know about Real-World Data and Real-World Evidence.

FDA 510(k) Recap: Companies Gaining First Clearances in 2018 and 2019

Products highlighted here — representing the spine, joint reconstruction, trauma and arthroscopy/soft tissue segments — include a total hip, cervical plate, interbody fusion system, lumbar fusion system, spacer, pedicle screw systems and more.