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U.S. Department of Health and Human Services

Product Classification

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Device posterior cervical screw system
Regulation Description Posterior cervical screw system.
Definition Posterior cervical screw systems are intended for use in fusion procedures of the cervical spine and/or craniocervical junction and/or cervicothoracic junction for: 1) spinal fractures and dislocations; 2) deformities; 3) instabilities; 4) failed previous fusions; 5) tumors; 6) inflammatory disorders; 7) spinal degeneration, 8) facet degeneration with instability; and 9) reconstruction following decompression to treat radiculopathy and/or myelopathy. These systems are also intended to stabilize the spine in the absence of fusion for a limited time period in patients with tumors involving the cervical spine in whom life expectancy is of insufficient duration to permit achievement of fusion.
Physical State Metallic plates, longitudinal members (e.g., rods) and other device-specific accessories.
Technical Method Use of screws and longitudinal members (e.g., rods) to stabilization spinal segments for fusion.
Target Area Posterior cervical spine
Regulation Medical Specialty Orthopedic
Review Panel Orthopedic
Product CodeNKG
Premarket Review Office of Orthopedic Devices (OHT6)
Spinal Devices (DHT6B)
Submission Type 510(k)
Regulation Number 888.3075
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
Recognized Consensus Standards
Third Party Review Not Third Party Eligible