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Automated Intraoperative Spinal Rod Bending System

FDA product code SIN · 1 cleared devices

Class 2 Orthopedic
Regulation
21 CFR 888.3070
Review panel
OR
Implant
No
Life sustaining
No
Third party review
No
GMP exempt
No
Clearance span
2026-06-25 – 2026-06-25

A rod bending system is intended to be used to intraoperatively bend thoracolumbosacral pedicle screw system rods by executing bending instructions in accordance with a user-defined rod plan to generate a patient-matched rod.

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