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U.S. Department of Health and Human Services

Product Classification

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Device orthosis, cervical pedicle screw spinal fixation
Definition This device is a posterior pedicle screw fixation system indicated for any of the following: Cervical spondylolisthesis (all grades and types) cervical spondylosis cervical degenerative disc disease degeneration of the cervical facets accompanied by instability cervical trauma (fracture dislocation) revision of failed previous fusion surgery (pseudoarthrosis) of the cervical spine
Physical State metallic plates and screws
Technical Method uses screws and plates to stabilize spinal segments for fusion
Target Area posterior cervical spine
Review Panel Orthopedic
Product CodeNKG
Premarket Review Office of Device Evaluation (ODE)
Division of Orthopedic Devices (DOD)
Posterior Spine Devices Branch (PSDB)
Unclassified Reason Pre-Amendment
Submission Type 510(k)
Device Class Unclassified
Total Product Life Cycle (TPLC) TPLC Product Code Report
GMP Exempt? No
Recognized Consensus Standards
Implanted Device? Yes
Life-Sustain/Support Device? No
Third Party Review Not Third Party Eligible