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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.
 
Trade NameEBI BONE HEALING SYSTEM
Classification Namestimulator, bone growth, non-invasive
Generic Namebone growth stimulator
ApplicantEBI ELECTRO BIOLOGY
PMA NumberP790002
Supplement NumberS023
Date Received06/17/2005
Decision Date09/26/2005
Product Code
LOF[ Registered Establishments with LOF ]
Advisory Committee General & Plastic Surgery
Supplement Typereal-time process
Supplement Reason change design/components/specifications - component
Expedited Review Granted? No
Combination Product No
Approval Order Statement 
Approval for three new coils: the flx 5, the xl coilette and the mini coilette and a modified version of the bone healing system model 2001 controller. The device, as modified, will be marketed under the trade name ebi bone healing system and is indicated for the treatment of fracture non-unions, failed fusions, and congenital pseudoarthroses in the appendicular system.
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