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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 may have changed. Be sure to look at the supplements to get an up-to-date view of this device.
 
Trade NameORTHOPAK(R) BONE GROWTH STIMULATOR
Classification Namestimulator, bone growth, non-invasive
Generic Namebone growth stimulator
ApplicantBIOMET, INC.
PMA NumberP850022
Date Received04/11/1985
Decision Date02/18/1986
Product Code
LOF[ Registered Establishments with LOF ]
Docket Number 86M-0139
Notice Date 04/09/1986
Advisory Committee Orthopedic
Expedited Review Granted? No
Combination Product No
Supplements: S001 S003 S004 S005 S006 S007 
S008 S009 S011 S012 S013 S014 
S015 S016 S017 S018 
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