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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 NameORTHOLOGIC 1000 BONE GROWTH STIMULATOR
Classification Namestimulator, bone growth, non-invasive
Generic Namebone growth stimulator
ApplicantORTHOLOGIC CORP.
PMA NumberP910066
Supplement NumberS004
Date Received04/05/1996
Decision Date06/25/1997
Product Code
LOF[ Registered Establishments with LOF ]
Advisory Committee Physical Medicine
Supplement Typenormal 180 day track
Supplement Reason change design/components/specifications - other
Expedited Review Granted? No
Combination Product No
Approval Order Statement 
Approval for the orthologic 1000 single closed coil soft pack bone growth stimulator in sizes xs, s, m, l, and xl and for the orthologic 1000 bone growth stimulator in the medium size. The devices, as modified, will be marketed under the trade names ol 1000-cc and ol 1000 (medium) and are indicated for the noninvasive treatment of an established nonunion acquired secondary to trauma, excluding vetebrae and all flat bones, where the width of the nonunion defect is less than one-half the width of the bone to be treated.
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