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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 Orthopedic Devices (OHT6)
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
Reporting
Eligible
Implanted Device? Yes
Life-Sustain/Support Device? No
Recognized Consensus Standards
Third Party Review Not Third Party Eligible
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