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U.S. Department of Health and Human Services

Product Classification
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Device growing rod system- magnetic actuation
Definition Stabilization or correction of spinal deformities without the use of fusion, using non-invasive methods to adjust the spinal rod.
Physical State Metalllic rods, monoaxial or polyaxial bone screws, hooks, magnetic remote control, and other related accessories.
Technical Method The system of distracting rods and fixation elements (screws, hooks, etc.) provides stabilization of severe spinal abnormalities and distraction of the rod as the child grows, via magnetic actuation.
Target Area Pediatric spine
Regulation Medical Specialty Orthopedic
Review Panel Orthopedic
Product CodePGN
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		 Eligible
Implanted Device? Yes
Life-Sustain/Support Device? No
Third Party Review Not Third Party Eligible
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