Product code OBL
- Device name
- Cement, Bone, Pre-Formed, Modular, Polymeric, Vertebroplasty
- Medical specialty
- Orthopedic
- Device class
- 2
- Regulation number
- 888.3027
- Review panel
- OR
- Implant
- Y
- Life sustaining/supporting
- N
- GMP exempt
- N
- Third party review
- N
- Summary malfunction reporting
- Eligible
- Definition
- Reduction of vertebral body fractures in conjunction with PMMA bone cement cleared for vertebroplasty and restoration of vertebral body height.
- Source
- FDA openFDA device classification dataset