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U.S. Department of Health and Human Services

Product Classification

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Device orthosis, spine, plate, laminoplasty, metal
Regulation Description Spinal interlaminal fixation orthosis.
Definition This device is a plate that is attached to the lamina after a laminoplasty or laminectomy procedure.
Regulation Medical Specialty Orthopedic
Review Panel Orthopedic
Product CodeNQW
Premarket Review Spinal Devices (DHT6B)
Spinal Devices (DHT6B)
Submission Type 510(k)
Regulation Number 888.3050
Device Class 2
Total Product Life Cycle (TPLC) TPLC Product Code Report
GMP Exempt? No
Summary Malfunction
Implanted Device? Yes
Life-Sustain/Support Device? No
Recognized Consensus Standards
Third Party Review Not Third Party Eligible