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U.S. Department of Health and Human Services

Product Classification

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Device growing rod system
Definition Stabilization or correction of spinal deformities without the use of fusion.
Physical State Metalllic rods, monoaxial or polyaxial bone screws, hooks, and other related accessories.
Technical Method The system of distracting or compressing rods and fixation elements (screws, hooks, etc.) provides stabilization and correction of the spine as the child grows.
Target Area Pediatric spine.
Review Panel Orthopedic
Product CodePGM
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
Implanted Device? Yes
Life-Sustain/Support Device? No
Third Party Review Not Third Party Eligible