Quick Links: Skip to main page content Skip to Search Skip to Topics Menu Skip to Common Links
  • Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

Product Classification
  • Print
  • Share
  • E-mail
-
New Search Back to Search Results
Device cement, bone, vertebroplasty, pre-formed, modular
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 Stereotaxic, Trauma and Restorative Devices (DHT6C)
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
-
-