SPINE‑FIX®
Spinal radiopaque bone cement

• Low viscosity
• 35% radiopaque agents; Barium Sulfate (BaSO4) and HydroxyApatite (HA) for X-ray visualisation
EU
SPINE-FIX® is intended for use in palliative percutaneous cementoplasty procedures (such as vertebroplasty or kyphoplasty) and in augmentation procedures (such as pedicular screw fixation).
U.S. INDICATIONS
SPINE-FIX® US cement is indicated for the fixation of pathological fractures of the vertebral body using vertebroplasty or kyphoplasty procedures. Painful vertebral compression fractures of the vertebral body may result from osteoporosis, benign lesions (hemangioma), or malignant lesions (metastatic cancers, myeloma).
| Designation | Reference |
|---|---|
| SPINE-FIX® | T040320S |
| SPINE-FIX® US | US040320S |
U.S. federal law restricts this device to sale by or on the order of a physician (or properly licensed practitioner) or on the physician’s prescription.