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U.S. Department of Health and Human Services

Premarket Approval (PMA)

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Note: this medical device record is a supplement. The device description may have changed. Be sure to look at the original PMA to get an up-to-date view of this device.
Classification Namestimulator, bone growth, non-invasive
Generic Namenon-invasive bone growth stimulator
ApplicantEBI, L.P.
PMA NumberP850022
Supplement NumberS018
Date Received06/13/2011
Decision Date08/11/2011
Product Code
LOF[ Registered Establishments with LOF ]
Advisory Committee Orthopedic
Supplement Typereal-time process
Supplement Reason change design/components/specifications - software
Expedited Review Granted? No
Combination Product No
Approval Order Statement 
Approval for the modification of the system software to include an additional line of code which would allow the real-time clock to reset to 'day zero' after an elapsed 365 days, this reset would allow your device to remain functional after 365 days of inactivity. The device, as modified, will be marketed under the trade names orthopak non-invasive bone growth stimulator system and spinalpak non-invasive spine fusion stimulator system and are indicated for the following: 1) the biomet orthopak non-invasive bone growth stimulator system is indicated for the treatment of an established nonunion acquired secondary to trauma, excluding vertebrae and all flat bones, where the width of the nonunion defect is less than one-half the width of the bone to be treated. A nonunion is considered to be established when the fracture site shows no visible progressive signs of healing; and 2) the biomet spinalpak non-invasive spine fusion stimulator system is indicated as an adjunct electrical treatment to primary lumbar spinal fusion surgery for one or two levels.