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U.S. Department of Health and Human Services

Product Classification

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Device cement, bone, pre-formed, modular, polymeric, vertebroplasty
Regulation Description Polymethylmethacrylate (PMMA) bone cement.
Definition Reduction of vertebral body fractures in conjunction with PMMA bone cement cleared for vertebroplasty and restoration of vertebral body height.
Physical State Interlocking pre-formed polymeric (e.g., PEEK) components sized to the desired vertebral body dimensions
Technical Method Implanted modularly within the vertebral body until desired height is achieved, then encapsulated in PMMA.
Target Area Thoracic or lumbar vertebral bodies
Regulation Medical Specialty Orthopedic
Review Panel Orthopedic
Product CodeOBL
Premarket Review Restorative, Repair and Trauma Devices (DHT6C)
Restorative, Repair and Trauma Devices (DHT6C)
Submission Type 510(k)
Regulation Number 888.3027
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