FDA-cleared K230252
OFIX MIS App
Orthofix US LLC
Authorized purpose: The OFIX MIS App assists healthcare professionals in viewing, storing, and measuring images and planning orthopedic surgeries, including measurements for placement of surgical implants.
- Modality
- Radiological images; modality varies or is not specified in FDA list
- Anatomy
- Patient-specific orthopedic surgical anatomy and implant-placement landmarks
- Decision
- 2023-09-26