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U.S. Department of Health and Human Services

Product Classification

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Device spinal vertebral body replacement device - cervical
Regulation Description Spinal intervertebral body fixation orthosis.
Definition Vertebral body replacement in the cervical spine.
Physical State Metallic or polymeric device (usually rectangular or cylindrical), with open central and lateral canals for bone graft containment, providing rigidity and structural support.
Technical Method Provides structural support for the indicated population.
Target Area Cervical spine
Regulation Medical Specialty Orthopedic
Review Panel Orthopedic
Product CodePLR
Premarket Review Orthopedic Devices (OHT6)
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
Implanted Device? Yes
Life-Sustain/Support Device? No
Third Party Review Not Third Party Eligible