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U.S. Department of Health and Human Services

Product Classification
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Device automated intraoperative spinal rod bending system
Regulation Description Thoracolumbosacral pedicle screw system.
Definition 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.
Physical State The device consists of both software and hardware components.
Technical Method The device uses electromechanical components that intraoperatively bends a spinal rod based on outputs from a software system to generate a patient-matched rod bending plan.
Target Area Spine
Regulation Medical Specialty Orthopedic
Review Panel Orthopedic
Product CodeSIN
Premarket Review Spinal Devices (DHT6B)
Spinal Devices (DHT6B)
Submission Type 510(k)
Regulation Number 888.3070
Device Class 2
Total Product Life Cycle (TPLC) TPLC Product Code Report
GMP Exempt? No
Summary Malfunction
Reporting		 Ineligible
Implanted Device? No
Life-Sustain/Support Device? No
Third Party Review Not Third Party Eligible
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