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U.S. Department of Health and Human Services

Product Classification

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Device appliance, fixation, spinal intervertebral body
Regulation Description Spinal intervertebral body fixation orthosis.
Regulation Medical Specialty Orthopedic
Review Panel Orthopedic
Product CodeKWQ
Premarket Review Spinal Devices (DHT6B)
Spinal Devices (DHT6B)
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
Implanted Device? Yes
Life-Sustain/Support Device? No
Recognized Consensus Standards
Guidance Document
Third Party Review Not Third Party Eligible
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