FDA-cleared K230252

OFIX MIS App

Orthofix US LLC

The OFIX MIS App assists healthcare professionals in viewing, storing, and measuring images and planning orthopedic surgeries, including measurements for placement of surgical...

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