Intended Use

The UNiD Spine Analyzer is intended for assisting healthcare professionals in viewing and measuring images as well as planning orthopedic surgeries. The device allows surgeons and service providers to perform generic, as well as spine related measurements on images, and to plan surgical procedures. The device also includes tools for measuring anatomical components for placement of surgical implants. Clinical judgment and experience are required to properly use the software.

Technology

The device is a software system compatible with Windows and Mac, designed to assist in image viewing and measurement, including spine-related and generic measurements, plus planning and implant placement. It includes a database of implants allowing users to draw and plan implant placement (cages, screws, rods) from a catalog of products. It operates as a PACS-compatible system with server capabilities.

Performance

Verification and validation testing was performed on the software, including the new implant database feature. Testing followed FDA guidance for software contained on medical devices. The software was considered moderate risk and performance testing showed no new safety or effectiveness issues.

Predicate Devices

No predicate devices specified

Device Timeline

  • 1

    Submission

    1/12/2018

    27 days
  • 2

    FDA Approval

    2/8/2018

Other devices from Medicrea International

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