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U.S. Department of Health and Human Services

Product Classification

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Device vertebroplasty compound, calcium based
Regulation Description Polymethylmethacrylate (PMMA) bone cement.
Definition THIS DEVICE IS INDICATED FOR THE FIXATION OF PATHOLOGICAL FRACTURES OF THE VERTEBRAL BODY USING VERTEBROPLASTY OR KYPHOPLASTY PROCEDURES. THE DEVICE RESORBS (TIME FRAME MAY BE INDICATED) AND IS REPLACED WITH BONE DURING THE HEALING PROCESS.
Regulation Medical Specialty Orthopedic
Review Panel Orthopedic
Product CodeNUD
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
Implanted Device? Yes
Life-Sustain/Support Device? No
Recognized Consensus Standards
Third Party Review Not Third Party Eligible
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