Product information on the Biomet® SpinalPak®
Non-invasive Spine Fusion Stimulator System
INDICATIONS: The Biomet® SpinalPak®
Non-invasive Spine Fusion Stimulator System is an FDA approved
noninvasive spine fusion stimulator indicated as an adjunct electrical
treatment to primary lumbar spinal fusion surgery for one or two levels.
USAGE: Federal Law (U.S.A.) restricts this device to sale by or
on the order of a physician. Rx Only - Prescription Only - Single
Patient Use Only - Not for Re-Sale or Re-Distribution - Do Not Reuse.
WARNINGS: The concomitant use of the device and a pacemaker or
cardioverter must be assessed on an individual basis, such as with an
electrocardiogram, prior to use. The patient should be referred to a
cardiologist for monitoring of pacemaker function while wearing the
active Biomet® SpinalPak® Non-invasive Spine Fusion
Stimulator System device. If there are any observable adverse changes
in the pacemaker rhythm or output, the device should not be used.
The safety and effectiveness of the Biomet®
SpinalPak® Non-invasive Spine Fusion Stimulator System in
pregnant women have not been studied, and the effects of the device on
the mother or the developing fetus are unknown. A patient who is
either pregnant or is intending to become pregnant should be referred
to her doctor prior to treatment with the device.
PRECAUTIONS: The Biomet® SpinalPak®
Non-invasive Spine Fusion Stimulator System has not been studied in
individuals with the following conditions: spondylitis, infection,
Paget’s disease, cancer, diabetes mellitus, renal disease, trauma of
the lumbar spine and osteoporosis: therefore, the safety and
effectiveness of the device in these individuals is unknown.
Complete prescribing information including warnings and precautions
associated with the use of this device may be found online at www.LearnAboutBoneHealing.com
or by contacting customer service at 1-800-526-2579, extension 6000.
However, if you have additional questions regarding your doctor’s
instructions in using this device, or you are experiencing any type of
reaction with the use of this device, contact your doctor immediately.
For further product information, including warnings, refer to the
Patient Manual at www.LearnAboutBoneHealing.com,
or contact Customer Service at 1-800-526-2579, extension 6000.