The Biomet SpinalPak Non-invasive Spine Fusion Stimulator
System is a non-invasive spine fusion stimulator indicated as an
adjunct electrical treatment to primary lumbar spinal fusion surgery
for one or two levels - P850022/S017.
The SpinalPak Non-invasive Spine Fusion Stimulator System is
designed to deliver 270 days of continuous therapeutic treatment for
24 hours per day. The recommended daily therapeutic treatment is
continuous for 24 hours. 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 - Do Not Reuse.
There are no known contraindications
regarding the use of the Biomet SpinalPak Non-Invasive Spine Fusion
For complete prescribing information including warnings and
precautions, please refer to the Biomet SpinalPak Non-invasive Spine
Fusion System Complete Manual and Package Insert or the Patient Manual
PN1067795-00 or PN1067796-00 or call 1-800-526-2579 extension 6000.
In support of their research for or preparation of this work, one or
more of the authors may have received remuneration from Zimmer Biomet.