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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 Office of Device Evaluation (ODE)
Division of Orthopedic Devices (DOD)
Posterior Spine Devices Branch (PSDB)
Submission Type 510(k)
Regulation Number 888.3050
Device Class 2
Total Product Life Cycle (TPLC) TPLC Product Code Report
GMP Exempt? No
Recognized Consensus Standards
Implanted Device? Yes
Life-Sustain/Support Device? No
Third Party Review Not Third Party Eligible