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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.
 
DeviceBiomet® OrthoPak® Non-invasive Bone Growth Stimulator System; Biomet® SpinalPak® Non-invasive Spine Fusion Stimulator Sy
Generic NameStimulator, bone growth, non-invasive
ApplicantAhp Eos Buyer, Inc.
1 Gatehall Dr.
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
Predetermined Change Control Plan AuthorizedNo
RecallsCDRH Recalls
Supplements:  S001 S003 S004 S005 S006 S007 S008 S009 S011 S012 S013 
S014 S015 S016 S017 S018 S020 S021 S022 S023 S024 S025 S026 
S027 S028 S029 S030 S031 S032 S033 S034 
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