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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