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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.
 
DeviceSONIC ACCELERATED FRACTURE HEALING SYSTEM MODEL 2A
Generic NameStimulator, bone growth, non-invasive
Regulation Number890.5870
ApplicantBioventus, LLC
4721 Emperor Blvd., Suite 100
Durham, NC 27703
PMA NumberP900009
Date Received02/01/1990
Decision Date10/05/1994
Reclassified Date05/18/2026
Product Code LOF 
Docket Number 94M-0363
Notice Date 11/09/1994
Advisory Committee Orthopedic
Expedited Review Granted? No
Combination ProductNo
Predetermined Change Control Plan AuthorizedNo
RecallsCDRH Recalls
Supplements: S001 S002 S003  S024 S012 S013 S007 S018 S019 S022 S006 
S010 S011 S014 S015 S041 S008 S009 S016 S017 S020 S021 S023 
S030 S032 S029 S025 S031 S042 S044 S043 S049 S050 S027 S028 
S039 S033 S038 S037 S046 S047 S036 S035 S048 
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