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FDA-cleared K242270

OrthoNext Platform System

Orthofix Srl

Authorized purpose: The OrthoNext Platform System is indicated to assist healthcare professionals in preoperative planning of orthopedic surgery and postoperative planning of orthopedic treatment. It overlays Orthofix product templates on radiological images and provides tools for image measurement and template positioning.

Modality
Radiological images; modality varies or is not specified in FDA list
Anatomy
Patient-specific orthopedic anatomy
Decision
2024-12-19