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U.S. Department of Health and Human Services

Product Classification

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Device cement, bone, vertebroplasty, pre-formed, modular
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 PMMA components sized to the desired vertebral body dimensions
Technical Method Implanted modularly within the vertebral body until desired dimensions are achieved, then encapsulated in PMMA
Target Area Thoracic or lumbar vertebral bodies
Regulation Medical Specialty Orthopedic
Review Panel Orthopedic
Product CodeOBM
Premarket Review Orthopedic Devices (OHT6)
Stereotaxic, Trauma and Restorative 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
Reporting
Eligible
Recognized Consensus Standards
Implanted Device? Yes
Life-Sustain/Support Device? No
Third Party Review Not Third Party Eligible
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