CMF SpinaLogic® Brief Prescribing Information

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INDICATION FOR USE

CMF SpinaLogic is a portable, battery-powered microcontrolled, noninvasive bone growth stimulator indicated as an adjunct electromagnetic treatment to primary lumbar spinal fusion surgery for one or two levels.

CONTRAINDICATIONS

Demand-type pacemaker and implantable cardiovertor defibrilator (ICD) operation may be adversely affected by exposure to combined static and dynamic magnetic fields. Physicians should not prescribe CMF SpinaLogic for patients with such devices.

The safety and effectiveness of SpinaLogic in pregnant women have not been studied, and the effects of the device on the mother or the developing fetus are unknown, thus, this device should not be used in pregnant women. If a woman becomes pregnant during treatment with CMF SpinaLogic, treatment should be discontinued immediately.

PRECAUTIONS

The safety and effectiveness of the use of this device on individuals lacking skeletal maturity has not been established.
  • The safety and effectiveness of this device in treating patients with the following conditions has not been established and therefore the safety and effectiveness of the device in these individuals is unknown: osseous or ligamentous spinal trauma, spondylitis, Paget's disease, severe osteoporosis, metastatic cancer, renal disease, and uncontrolled diabetes mellitus.
  • Animal studies conducted to date do not suggest any long term adverse effects from the use of this device. However, long term effects in humans are unknown.
  • Compliance with the treatment schedule, timely battery change and proper care of the device are essential. The device will not perform properly and treatment may be unnecessarily prolonged if the patient fails to adhere to the care routine.
  • This device should not be used if there are mental or physical conditions which preclude patient compliance with the physician and device instructions.

    • ADVERSE EFFECTS

    No known significant adverse effects have resulted from the use of this device. Clinical studies, animal studies, and tissue culture experiments conducted with the CMF SpinaLogic Bone Growth Stimulator magnetic fields have not indicated any evidence of significant adverse effects.

    CAUTION

    Federal law (USA) restricts this device to sale by or on the order of a physician. For full prescribing information, contact DJO, LLC.

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