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U.S. Department of Health and Human Services

Product Classification

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Device appliance, fixation, spinal interlaminal
Regulation Description Spinal interlaminal fixation orthosis.
Regulation Medical Specialty Orthopedic
Review Panel Orthopedic
Product CodeKWP
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
Third Party Review Not Third Party Eligible
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