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U.S. Department of Health and Human Services

Product Classification

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Device implant, fixation device, spinal
Regulation Description Spinal intervertebral body fixation orthosis.
Regulation Medical Specialty Orthopedic
Review Panel Orthopedic
Product CodeJDN
Premarket Review Orthopedic Devices (OHT6)
Restorative, Repair and Trauma Devices (DHT6C)
Submission Type 510(k)
Regulation Number 888.3060
Device Class 2
Total Product Life Cycle (TPLC) TPLC Product Code Report
GMP Exempt? No
Summary Malfunction
Reporting
Eligible
Recognized Consensus Standards
Implanted Device? Yes
Life-Sustain/Support Device? No
Third Party Review Not Third Party Eligible
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