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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® SpinalPak® Non-invasive Spine Fusion Stimulator System, Biomet® OrthoPak® Non-invasive Bone Growth Stimulator Sy
Generic NameStimulator, bone growth, non-invasive
Regulation Number890.5870
ApplicantAhp Eos Buyer, Inc.
1 Gatehall Dr.
Suite 303
Parsippany, NJ 07054
PMA NumberP850022
Supplement NumberS034
Date Received12/01/2023
Decision Date02/29/2024
Reclassified Date05/18/2026
Product Code LOF 
Advisory Committee Orthopedic
Supplement TypeReal-Time Process
Supplement Reason Change Design/Components/Specifications/Material
Expedited Review Granted? No
Combination ProductNo
Predetermined Change Control Plan AuthorizedNo
Approval Order Statement  
Approval for a minor material change to the patient lead cable insulation (i.e., the extruded jacket).
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