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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.
 
DeviceXstim Spine Fusion Stimulator
Generic NameStimulator, bone growth, non-invasive
ApplicantXstim Inc
1231 Greenway Drive. Suite 260
Irving, TX 75038
PMA NumberP230025
Date Received08/15/2023
Decision Date02/09/2024
Product Code LOF 
Docket Number 24M-0782
Notice Date 02/21/2024
Advisory Committee Orthopedic
Expedited Review Granted? No
Combination ProductNo
Approval Order Statement  
The Xstim Spine Fusion Stimulator is a non-invasive bone growth stimulator indicated as an adjunct electrical treatment to primary lumbar spinal fusion surgery for one or two levels. The device is for prescription use only and is intended for single patient use in adult patients only.
Approval OrderApproval Order
SummarySummary of Safety and Effectiveness
LabelingLabeling
Labeling Part 2
Supplements:  S001 
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