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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
Review Panel Orthopedic
Product CodePGN
Premarket Review Office of Device Evaluation (ODE)
Division of Orthopedic Devices (DOD)
Posterior Spine Devices Branch (PSDB)
Unclassified Reason Pre-Amendment
Submission Type 510(k)
Device Class Unclassified
Total Product Life Cycle (TPLC) TPLC Product Code Report
GMP Exempt? No
Third Party Review Not Third Party Eligible
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