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U.S. Department of Health and Human Services

Premarket Approval (PMA)
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Note: this medical device has supplements. The device description/function or indication may have changed. Be sure to look at the supplements to get an up-to-date information on device changes. The labeling included below is the version at time of approval of the original PMA or panel track supplement and may not represent the most recent labeling.
 
DeviceORTHOPAK(R) BONE GROWTH STIMULATOR
Generic NameStimulator, bone growth, non-invasive
ApplicantEBI, LLC
1 Gatehall Drive
Suite 303
Parsippany, NJ 07054
PMA NumberP850022
Date Received04/11/1985
Decision Date02/18/1986
Product Code LOF 
Docket Number 86M-0139
Notice Date 04/09/1986
Advisory Committee Orthopedic
Expedited Review Granted? No
Combination ProductNo
RecallsCDRH Recalls
Supplements: S018 S001 S003 S004 S005 S006 S007 S008  S009 S012 S020 
S026 S023 S016 S011 S013 S015 S014 S027 S021 S025 S024 S022 
S017 S028 S029 S030 S031 S033 S034 S032 
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