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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 PMA supplement. A supplement may have changed the device description/function or indication from that approved in the original PMA. Be sure to look at the original PMA record for more information.
 
DeviceBIOMET ORTHOPAK NON INVASIVE BONE GROWTH STIMULATOR SYSTEM, BIOMET SPINALPAK NON INVASIVE SPINE FUSION STIMULATOR SYSTEM
Generic NameStimulator, bone growth, non-invasive
ApplicantEBI, LLC
1 Gatehall Drive
Suite 303
Parsippany, NJ 07054
PMA NumberP850022
Supplement NumberS028
Date Received11/08/2016
Decision Date12/08/2016
Product Code LOF 
Advisory Committee Orthopedic
Supplement Type30-Day Notice
Supplement Reason Process Change - Manufacturer/Sterilizer/Packager/Supplier
Expedited Review Granted? No
Combination ProductNo
Approval Order Statement  
Qualification of an alternate supplier to provide electronic printed circuit boards (PCBs) for the three device systems. The change is being made to qualify an alternate secondary-supplier for the PCBs to complement existing approved suppliers in order to further secure the supply chain for critical components to these device systems. The following Zimmer Biomet manufacturing and distribution facility is affected by the changes: EBI Patient Care Inc., Guaynabo, Puerto Rico.
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