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U.S. Department of Health and Human Services

Product Classification

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Device hemibridge system
Definition Non-fusion growth modulation of spinal column.
Physical State Metallic plate or staple with fixation elements
Technical Method An antero-lateral growth plate intended to attach to vertebral bodies in order to modulate growth of the spinal column
Target Area Anterior spinal column
Review Panel Orthopedic
Product CodePFM
Premarket Review Office of Orthopedic Devices (OHT6)
Spinal Devices (DHT6B)
Not Classified Reason For Export Only
Submission Type Contact ODE
Device Class Not Classified
Total Product Life Cycle (TPLC) TPLC Product Code Report
GMP Exempt? No
Summary Malfunction
Implanted Device? Yes
Life-Sustain/Support Device? No
Third Party Review Not Third Party Eligible