FDA approves Mighty Oak Medical’s pedicle screw navigation guide: 5 key notes

Mighty Oak Medical received 510(k) approval from the FDA for its FIREFLY Pedicle Screw Navigation Guide.

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Here are five key notes:

 

1. FIREFLY technology aims to enable optimal implant placement.

 

2. It incorporates surgeon-defined parameters for screw diameter, medial line angle and entry point into the design of the patient-specific guides.

 

3. FIREFLY guides do not have a proprietary screw system and can be used with multiple pedicle screw manufacturer’s systems.

 

4. The technology also uses 3D printing.

 

5. The FIREFLY technology was awarded the Spine Technology Award in 2012 from the state of Colorado.

 

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